This guideline document was prepared by the Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy using the best available scientific evidence and considering a multitude of variables including but not limited to adverse events, patient values, and cost implications. The purpose of these guidelines is to provide the best practice recommendations that may help standardize patient care, improve patient outcomes, and reduce variability in practice. We recognize that clinical decision-making is complex. Guidelines, therefore, are not a substitute for a clinician’s judgment. Such judgments may at times seem contradictory to our guidance because of many factors that are impossible to fully consider by guideline developers. Any clinical decisions should be based on the clinician’s experience, local expertise, resource availability, and patient values and preferences. This document is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating for, mandating, or discouraging any particular treatment. Our guidelines should not be used in support of medical complaints, legal proceedings, and/or litigation as they were not designed for this purpose.
GERD, defined as troublesome heartburn and/or regurgitation, is the most prevalent GI disorder, affecting one-third of the adult population in the United States.
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Prevalence of gastroesophageal reflux disease and proton pump inhibitor-refractory symptoms
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GERD can also be present in the pediatric population but may be difficult to establish because of patients’ limitations in describing these symptoms.
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Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition
J Pediatr Gastroenterol Nutr. 2018; 66:516-554
Chronic uncontrolled acid reflux could lead to several adverse events including erosive esophagitis, peptic stricture, Barrett’s esophagus (BE), and esophageal adenocarcinoma. The incidence of GERD and GERD-related consequences appears to be increasing in parallel with global prevalence of obesity.
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In addition, GERD can result in poor quality of life and increased healthcare costs to individuals and the healthcare system because of frequent physician visits, endoscopies, and treatment of GERD-related consequences.
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Systematic review: the association between symptomatic response to proton pump inhibitors and health-related quality of life in patients with gastro-oesophageal reflux disease
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Since the publication of the previous American Society for Gastrointestinal Endoscopy (ASGE) guideline on GERD,
99.
ASGE Standards of Practice Committee ∙ Muthusamy, V.R. ∙ Lightdale, J.R. ...
The role of endoscopy in the management of GERD
Gastrointest Endosc. 2015; 81:1305-1310
there have been several endoscopic advancements that can affect the diagnosis and management of GERD. These include evolving indications for endoscopy among patients after sleeve gastrectomy (SG) and peroral endoscopic myotomy (POEM) in addition to updated guidance regarding endoscopic antireflux therapies. Therefore, the ASGE aimed to develop an updated and revised evidence-based guideline on the diagnosis and management of GERD.
Methods
This document was prepared by the Standards of Practice Committee of the ASGE and was conceptualized and conducted according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.
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Guyatt, G.H. ∙ Oxman, A.D. ∙ Vist, G.E. ...
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The recommendations in this summary document were carefully crafted and informed by the best available evidence. Evidence profiles were created by GRADE methodologists. Evidence was presented to a panel of experts representing various stakeholders in a meeting held in the IT&T center, Chicago, Illinois, USA on March 10, 2023. All panel members were required to disclose potential financial and intellectual conflicts of interests, which were addressed according to ASGE policies. Panelists and primary methodologists with conflicts of interest were excluded from voting on final recommendations.
In developing these recommendations, we took into consideration the certainty of the evidence, benefits and harms of different management options, feasibility, patient values and preferences, resource utilization, cost-effectiveness, and health equity, wherever possible. Final approval of each recommendation was based on a simple majority among the panel members. The final wording of the recommendations including direction and strength were approved by all members of the panel. The final wording of our recommendations was approved by all members of the panel and the ASGE Governing Board. Stronger recommendations are represented using statements such as “we recommend…,” whereas weaker recommendations are represented by statements such as “we suggest….” This document, subtitled “Summary and Recommendations,” provides our final recommendations as well as a high-level summary of the evidence-based guideline process that was followed by the ASGE in preparing this document. Further details on methodology and evidence synthesis process are provided separately including details of our literature search, data analyses, pooled-effects estimates, evidence profiles, forest plots, and panel deliberation for each outcome in the accompanying methodology and technical review document.
This guideline addressed the following clinical domains in the following categories using the GRADE format: endoscopy in specific patient populations to evaluate for GERD (questions 1a, 1b, and 1c), performance of a high-quality endoscopy (question 2), lifestyle interventions for management of GERD (question 3), use of proton pump inhibitors (PPIs) in GERD (question 4), and endoscopic management of GERD (questions 5 and 6). Relevant clinical outcomes included symptom remission, adverse events, objective improvement of GERD, durable response, and PPI discontinuation.
External review
The guideline was reviewed by the Gastrointestinal Endoscopy Editorial Board and ASGE Governing Board and made available for public comment on the ASGE website for 30 days between March 1 and April 1, 2024.
Results and Summary of Recommendations
A summary of our final recommendations for management of patients with GERD is listed in
Table 1. A management algorithm for patients with GERD is provided in
Figure 1.
Summary of the evidence
For this outcome, we used existing consensus from our previous guidelines.
99.
ASGE Standards of Practice Committee ∙ Muthusamy, V.R. ∙ Lightdale, J.R. ...
The role of endoscopy in the management of GERD
Gastrointest Endosc. 2015; 81:1305-1310
11.
ASGE Standards of Practice Committee ∙ Qumseya, B. ∙ Sultan, S. ...
ASGE guideline on screening and surveillance of Barrett’s esophagus
Gastrointest Endosc. 2019; 90:335-359
A clinical diagnosis of GERD can be made based on symptoms and confirmed by a favorable symptomatic response to antisecretory medical therapy. If the patient’s symptoms are consistent with typical or uncomplicated GERD, an initial trial of empirical medical therapy is appropriate before consideration of endoscopy in most patients without alarm symptoms. However, endoscopy at presentation should be considered in patients who have symptoms suggestive of advanced pathology or adverse events of GERD (ie, stricture). Endoscopy is therefore recommended for patients with alarm symptoms including dysphagia, odynophagia, weight loss, GI bleeding, and anemia.
The panel discussed that a high-quality EGD should be performed when alarm symptoms have occurred after a recent endoscopic evaluation in the absence of such symptoms. EGD may be necessary to detect erosive esophagitis, peptic stricture, esophageal cancer, gastric or esophageal outlet obstruction, and other potentially significant upper GI tract findings. Previous ASGE guidelines suggest screening endoscopy in at-risk patients, which is defined as individuals with a family history of BE or esophageal adenocarcinoma or patients with GERD plus at least 1 other risk factor.
99.
ASGE Standards of Practice Committee ∙ Muthusamy, V.R. ∙ Lightdale, J.R. ...
The role of endoscopy in the management of GERD
Gastrointest Endosc. 2015; 81:1305-1310
The panel recognized recent guidelines suggesting screening for patients with multiple risk factors (without necessarily having GERD as a prerequisite)
1111.
ASGE Standards of Practice Committee ∙ Qumseya, B. ∙ Sultan, S. ...
ASGE guideline on screening and surveillance of Barrett’s esophagus
Gastrointest Endosc. 2019; 90:335-359
because many patients with GERD and BE are asymptomatic.
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Gerson, L.B. ∙ Shetler, K. ∙ Triadafilopoulos, G.
Prevalence of Barrett’s esophagus in asymptomatic individuals
Gastroenterology. 2002; 123:461-467
Additionally, EGD should be considered as part of the preoperative evaluation of patients being considered for antireflux surgery or for the placement of wireless esophageal pH monitoring devices and is an inherent part of various endoscopic antireflux procedures. The panel supported these established recommendations, and these were incorporated into the existing indications for endoscopy for GERD.
Summary of the evidence
We found no prospective studies examining the utility of a screening EGD after SG for BE in terms of survival (or other events) or cost-effectiveness of screening in this population. We identified a systematic review by Qumseya et al
1313.
Qumseya, B.J. ∙ Qumsiyeh, Y. ∙ Ponniah, S.A. ...
Barrett’s esophagus after sleeve gastrectomy: a systematic review and meta-analysis
Gastrointest Endosc. 2021; 93:343-352
that assessed the rate of de novo BE after SG. Among 10 observational studies where 680 patients did not have BE before undergoing SG, 11.4% (54/680) developed BE after SG (7.7%-16.6%,
P < .001,
I2 = 28.7%) at follow-up ranging from 6 months to 10 years. In 5 studies with long-term follow-up, the relative increase in the rate of esophagitis was 86% (64%-109%,
P < .001,
I2 = 47%).
14-1914.
Salminen, P. ∙ Grönroos, S. ∙ Helmiö, M. ...
Effect of laparoscopic sleeve gastrectomy vs Roux-en-Y gastric bypass on weight loss, comorbidities, and reflux at 10 years in adult patients with obesity: the SLEEVEPASS randomized clinical trial
JAMA Surg. 2022; 157:656-666
15.
Sebastianelli, L. ∙ Benois, M. ∙ Vanbiervliet, G. ...
Systematic endoscopy 5 years after sleeve gastrectomy results in a high rate of Barrett’s esophagus: results of a multicenter study
Obes Surg. 2019; 29:1462-1469
16.
Soricelli, E. ∙ Casella, G. ∙ Baglio, G. ...
Lack of correlation between gastroesophageal reflux disease symptoms and esophageal lesions after sleeve gastrectomy
Surg Obes Relat Dis. 2018; 14:751-756
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Elkassem, S.
Endoscopic surveillance three to five years post sleeve gastrectomy: possible progression to reflux esophagitis and Barretts. In: Obesity Surgery
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Csendes, A. ∙ Orellana, O. ∙ Martínez, G. ...
Clinical, endoscopic, and histologic findings at the distal esophagus and stomach before and late (10.5 years) after laparoscopic sleeve gastrectomy: results of a prospective study with 93% follow-up
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19.
Dimbezel, V. ∙ Nedelcu, A. ∙ Danan, M. ...
Endoscopic findings 5 years following sleeve gastrectomy
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Meta-regression showed that the risk of esophagitis increased by 8% each year. We did not find any relevant data on patient values and preferences.
The panel noted that this risk of BE crosses the 10% threshold set by previous guidelines and thus suggested screening in this patient population.
1111.
ASGE Standards of Practice Committee ∙ Qumseya, B. ∙ Sultan, S. ...
ASGE guideline on screening and surveillance of Barrett’s esophagus
Gastrointest Endosc. 2019; 90:335-359
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Sawhney, M.S. ∙ Calderwood, A.H. ∙ Thosani, N.C. ...
ASGE guideline on screening for pancreatic cancer in individuals with genetic susceptibility: summary and recommendations
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Screening is suggested to start at 3 years, regardless of the presence of GERD symptoms, and should continue every 5 years thereafter. If BE is found, then surveillance should follow the recommendations of the previous ASGE guidance.
1111.
ASGE Standards of Practice Committee ∙ Qumseya, B. ∙ Sultan, S. ...
ASGE guideline on screening and surveillance of Barrett’s esophagus
Gastrointest Endosc. 2019; 90:335-359
Summary of the evidence
For this question, we performed a systematic review of studies examining the incidence of de novo GERD after POEM. Outcomes of interest were GERD, erosive esophagitis, and BE. We identified 3 existing systematic reviews and meta-analyses
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Repici, A. ∙ Fuccio, L. ∙ Maselli, R. ...
GERD after per-oral endoscopic myotomy as compared with Heller’s myotomy with fundoplication: a systematic review with meta-analysis
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Facciorusso, A. ∙ Singh, S. ∙ Abbas Fehmi, S.M. ...
Comparative efficacy of first-line therapeutic interventions for achalasia: a systematic review and network meta-analysis
Surg Endosc. 2021; 35:4305-4314
23.
Vespa, E. ∙ Pellegatta, G. ∙ Chandrasekar, V.T. ...
Long-term outcomes of peroral endoscopic myotomy for achalasia: a systematic review and meta-analysis
Endoscopy. 2023; 55:167-175
and 2 randomized controlled trials (RCTs).
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Ponds, F.A. ∙ Fockens, P. ∙ Lei, A. ...
Effect of peroral endoscopic myotomy vs pneumatic dilation on symptom severity and treatment outcomes among treatment-naive patients with achalasia: a randomized clinical trial
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Werner, Y.B. ∙ Hakanson, B. ∙ Martinek, J. ...
Endoscopic or surgical myotomy in patients with idiopathic achalasia
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In a meta-analysis of 17 observational studies (follow-up, 2-30 months), the rate of post-POEM de novo GERD was 19% (245/1275; 15.7%-22.8%,
I2 = 43.3%,
P = .024).
2121.
Repici, A. ∙ Fuccio, L. ∙ Maselli, R. ...
GERD after per-oral endoscopic myotomy as compared with Heller’s myotomy with fundoplication: a systematic review with meta-analysis
Gastrointest Endosc. 2018; 87:934-943
The pooled rate of esophagitis was 29.4% (449/1056; 18.5%-43.3%,
I2 = 93%,
P < .01). In a meta-analysis of 11 studies encompassing 2342 patients that examined GERD after POEM with a median follow-up of 48 months (2017-2021), the pooled rate of symptomatic reflux was 22.0% (95% confidence interval [CI], 14.4-29.5;
I2 = 73.1%,
P < .01), with 3 cases of peptic strictures and 1 case of BE identified.
2323.
Vespa, E. ∙ Pellegatta, G. ∙ Chandrasekar, V.T. ...
Long-term outcomes of peroral endoscopic myotomy for achalasia: a systematic review and meta-analysis
Endoscopy. 2023; 55:167-175
We did not identify other long-term data reporting a high rate of BE after POEM. We did not identify studies reporting patient values, cost-effectiveness, mortality, or benefits from surveillance or equity.
Overall, the evidence was noted to be of very low quality. The panel acknowledged that there was a high rate of GERD in initial studies after POEM; however, the POEM technique has also improved over time, correlating with decreased GERD rates after POEM. In addition, some studies have not examined rates of acid exposure before and after the intervention. Data on severity of esophagitis after POEM are also not consistently reported. The panel expressed concern regarding disruption of the antireflux barrier irrespective of POEM technique and acknowledged the risk of GERD after POEM. The panel also discussed the varying sensitivity for symptoms related to reflux and a higher incidence of esophagitis compared with reported symptoms among this population. Squamous cell cancer of the esophagus is associated with long-term achalasia, and esophageal adenocarcinoma is associated with longstanding acid reflux. Therefore, the panel acknowledged the utility of endoscopy in achalasia patients after POEM; however, the evidence in favor of EGD for all these patients is insufficient. The panel did make a conditional recommendation for EGD for further evaluation only in symptomatic patients after POEM.
Summary of the evidence
This was an important question to address for our guideline panel, especially given recent advancements in the endoscopic management of GERD. This is not a comparative question and thus did not follow the PICO (population, intervention, comparator, outcome) format. We performed a literature search for studies reporting the use of endoscopic evaluation modalities for GERD. Limited data describe the standardization of procedural documentation of upper endoscopies including documentation of the gastroesophageal junction. A study demonstrated that endoscopists are inconsistent in their reporting of upper endoscopies.
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Boys, J.A. ∙ Azadgoli, B. ∙ Martinez, M. ...
Adequacy of EGD reporting: a review of 100 reports from 100 endoscopists
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Specifically, esophagitis was documented in only one-third of patients and was graded in 42%. Furthermore, a hiatal hernia was noted in 61% of patients but only measured in 51% and further classified in 26%.
The panel agreed on the need to standardize endoscopy procedural documentation in patients with GERD because there can be negative consequences with failure to do so, including the need for a repeat endoscopy to characterize hiatal hernias and to document landmarks including the gastroesophageal junction before endoscopic or surgical therapy. This could subsequently delay therapeutic management and increase costs and risks associated with additional endoscopy.
2727.
ASGE Standards of Practice Committee ∙ Coelho-Prabhu, N. ∙ Forbes, N. ...
Adverse events associated with EGD and EGD-related techniques
Gastrointest Endosc. 2022; 96:389-401
The panel unanimously agreed that reporting objective findings of GERD is important, such as the presence of erosive esophagitis (Fig. 2A), BE (Prague classification) (
Fig. 2B),
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The development and validation of an endoscopic grading system for Barrett’s esophagus: the Prague C & M criteria
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and peptic strictures. Los Angeles grading should be used to assess the severity of esophagitis.
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The panel also agreed that reporting gastroesophageal junction landmarks and integrity is important. These include descriptions of hiatal hernia size, presence or absence of a flap valve using the forward endoscopic view and retroflexion in fundus, and use of Hill grading
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or American Foregut Society classification (
Fig. 2C) for gastroesophageal junction integrity and hiatus.
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The American Foregut Society white paper on the endoscopic classification of esophagogastric junction integrity
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The panel also discussed the importance of adequate mucosal inspection and cleanliness (including use of existing scales, ie, Barcelona scale
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Applicability of the Barcelona scale to assess the quality of cleanliness of mucosa at esophagogastroduodenoscopy
Gastroenterol Hepatol. 2024; 47:246-252
and Toronto Upper Gastrointestinal Cleaning Score
3333.
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) to ensure detection of any precancerous lesions before making definitive management decisions and emphasized achieving a high-quality inspection during the standard EGD.
Summary of the evidence
For this question, we performed a systematic literature search to evaluate the role of different lifestyle modifications (eg, weight loss, smoking cessation, head of bed elevation, late evening meals) on reduction of GERD symptoms. Weight loss was associated with a decrease in GERD symptoms and acid exposure time (3 RCTs
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Mathus-Vliegen, E.M.H. ∙ Tygat, G.N.J.
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35.
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Twenty-four-hour pH measurements in morbid obesity: effects of massive overweight, weight loss and gastric distension
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36.
Mathus-Vliegen, E.M.H. ∙ van Weeren, M. ∙ van Eerten, P.V.
LOS function and obesity: the impact of untreated obesity, weight loss, and chronic gastric balloon distension
Digestion. 2003; 68:161-168
) and improvement in reflux disease questionnaire scores (1 RCT
3737.
Singh, M. ∙ Lee, J. ∙ Gupta, N. ...
Weight loss can lead to resolution of gastroesophageal reflux disease symptoms: a prospective intervention trial
Obesity. 2013; 21:284-290
). Large population-based studies showed a linear relationship between body mass index and GERD symptoms.
3838.
Ness-Jensen, E. ∙ Lindam, A. ∙ Lagergren, J. ...
Weight loss and reduction in gastroesophageal reflux. A prospective population-based cohort study: the HUNT study
Am J Gastroenterol. 2013; 108:376-382
39.
Jacobson, B.C. ∙ Somers, S.C. ∙ Fuchs, C.S. ...
Body-mass index and symptoms of gastroesophageal reflux in women
N Engl J Med. 2006; 354:2340-2348
Smoking cessation was associated with decreased reflux symptoms.
4040.
Ness-Jensen, E. ∙ Lindam, A. ∙ Lagergren, J. ...
Tobacco smoking cessation and improved gastroesophageal reflux: a prospective population-based cohort study: the HUNT study
Am J Gastroenterol. 2014; 109:171-177
41.
Kohata, Y. ∙ Fujiwara, Y. ∙ Watanabe, T. ...
Long-term benefits of smoking cessation on gastroesophageal reflux disease and health-related quality of life
PloS One. 2016; 11, e0147860
Elevating the head of the bed was linked to lower reflux episodes
4242.
Stanciu, C. ∙ Bennett, J.R.
Effects of posture on gastro-oesophageal reflux
Digestion. 1977; 15:104-109
and decreased acid exposure.
4343.
Hamilton, J.W. ∙ Boisen, R.J. ∙ Yamamoto, D.T. ...
Sleeping on a wedge diminishes exposure of the esophagus to refluxed acid
Dig Dis Sci. 1988; 33:518-522
A late evening meal was associated with increased reflux.
4444.
Piesman, M. ∙ Hwang, I. ∙ Maydonovitch, C. ...
Nocturnal reflux episodes following the administration of a standardized meal. Does timing matter?
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On the other hand, we did not identify any data to demonstrate that alcohol cessation improves GERD symptoms to make a recommendation.
Other lifestyle interventions were assessed including decreased ingestion of various beverages and foods, but the data were not conclusive for improvement of GERD symptoms with these lifestyle modifications. We did not identify data on cost-effectiveness, equity, or patient preferences of these interventions. We relied on our patient advocate who opted in for conservative measures over medications or surgery if they help with symptom reduction or remission.
Overall, the certainty of evidence was low. Given the low cost of these interventions as well as the potential additional health benefits of these lifestyle interventions, the panel agreed that these lifestyle modifications should be recommended to decrease GERD symptoms based on the evidence available.
Summary of the evidence
We performed a systematic review to examine the outcomes of PPIs versus placebo on GERD symptoms. Outcomes examined were GERD symptom remission, healing of esophagitis, and adverse events from PPIs.
For outcomes of symptom remission and resolution of esophagitis, our search identified 22 RCTs and a network meta-analysis.
4545.
Zhang, C. ∙ Kwong, J.S.W. ∙ Yuan, R.X. ...
Effectiveness and tolerability of different recommended doses of PPIs and H2RAs in GERD: network meta-analysis and GRADE system
Sci Rep. 2017; 7, 41021
Patients with GERD taking PPIs were more likely to have symptom relief (pooled odds ratio [OR], 4.2; 95% CI, 3.25-5.48;
P < .01) and healing of erosive esophagitis compared with those not taking a PPI (OR, 11.4; 95% CI, 8.17-16.3;
P < .01). This network meta-analysis did not assess for heterogeneity (
I2) for these outcomes.
For adverse events, the best evidence came from a large RCT that found no significant difference in most adverse events at a mean follow-up of 3 years among PPI users (n = 8791) compared with nonusers (n = 8807).
4646.
Moayyedi, P. ∙ Eikelboom, J.W. ∙ Bosch, J. ...
Safety of proton pump inhibitors based on a large, multi-year, randomized trial of patients receiving rivaroxaban or aspirin
Gastroenterology. 2019; 157:682-691
Specifically, no significant difference was found in all-cause mortality (hazard ratio [HR], 1.03; 95% CI, .92-1.15); cardiovascular events including myocardial infarction, stroke, and death (hazard ratio, 1.04; 95% CI, .93-1.15); chronic kidney disease (OR, 1.17; 95% CI, .94-1.45);
Clostridium difficile infection (OR, 2.26; 95% CI, .7-7.34); pneumonia (OR, 1.02; 95% CI, .87-1.19); fractures (OR, .96; 95% CI, .79-1.17); and dementia (OR, 1.2; 95% CI, .81-1.78).
4646.
Moayyedi, P. ∙ Eikelboom, J.W. ∙ Bosch, J. ...
Safety of proton pump inhibitors based on a large, multi-year, randomized trial of patients receiving rivaroxaban or aspirin
Gastroenterology. 2019; 157:682-691
In this RCT, patients on PPIs were at a higher risk of other enteric infections compared with nonusers (OR, 1.33; 95% CI, 1.01-1.75;
P = .04).
PPIs were more effective in relieving heartburn in comparison with ranitidine; however, the use of PPIs in managing heartburn in patients with long-term consumption of nonsteroidal anti-inflammatory drugs was found to have higher cost compared with H2 blockers.
4747.
Jamshed, S. ∙ Bhagavathula, A.S. ∙ Zeeshan Qadar, S.M. ...
Cost-effective analysis of proton pump inhibitors in long-term management of gastroesophageal reflux disease: a narrative review
Hosp Pharm. 2020; 55:292-305
For patient values and preferences, we identified a review of 12 eligible studies (7 surveys, 4 qualitative studies, and 1 RCT) examining patient values and preferences.
4848.
Thompson, W. ∙ Black, C. ∙ Welch, V. ...
Patient values and preferences surrounding proton pump inhibitor use: a scoping review
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These studies suggested that PPI de-escalation is a preference-sensitive decision; therefore, patient attitudes should be elicited and incorporated into the decision-making process.
PPI metabolism is affected by the genotypical variability of
CYP2C19, which encodes the CYP450 isoenzyme. Although it has not largely been implemented in practice, there may be a role for assessment of
CYP2C19 polymorphism and adjusting PPI therapy in patients who have GERD refractory to PPI therapy. Our literature search found a meta-analysis of 19 studies showing a role of assessing
CYP2C19 polymorphism and its impact on GERD symptoms.
4949.
Ichikawa, H. ∙ Sugimoto, M. ∙ Sugimoto, K. ...
Rapid metabolizer genotype of CYP2C19 is a risk factor of being refractory to proton pump inhibitor therapy for reflux esophagitis
J Gastroenterol Hepatol. 2016; 31:716-726
In this meta-analysis, analysis of 8 studies showed that rapid metabolizers with reflux esophagitis have an increased risk of being refractory to PPI therapy compared with poor metabolizers (OR, 1.66; 95% CI, 1.02-2.66;
P = .04). Thus, for patients who are rapid or ultrarapid metabolizers, the PPI dosage should be increased to 3 times daily or switched to a different PPI, such as rabeprazole, which is less reliant on this metabolic pathway than other PPIs.
Overall, the certainty of the evidence supporting the use of PPI therapy was moderate. Although PPI efficacy has been well established by high-quality studies in GERD, previous retrospective studies
50-5750.
Yang, Y.X. ∙ Lewis, J.D. ∙ Epstein, S. ...
Long-term proton pump inhibitor therapy and risk of hip fracture
JAMA. 2006; 296:2947-2953
51.
Charlot, M. ∙ Grove, E.L. ∙ Hansen, P.R. ...
Proton pump inhibitor use and risk of adverse cardiovascular events in aspirin treated patients with first time myocardial infarction: nationwide propensity score matched study
BMJ. 2011; 342, d2690
52.
Lazarus, B. ∙ Chen, Y. ∙ Wilson, F.P. ...
Proton pump inhibitor use and the risk of chronic kidney disease
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53.
Gomm, W. ∙ von Holt, K. ∙ Thomé, F. ...
Association of proton pump inhibitors with risk of dementia: a pharmacoepidemiological claims data analysis
JAMA Neurol. 2016; 73:410-416
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Laheij, R.J.F. ∙ Sturkenboom, M.C.J.M. ∙ Hassing, R.J. ...
Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs
JAMA. 2004; 292:1955-1960
55.
Xie, Y. ∙ Bowe, B. ∙ Li, T. ...
Risk of death among users of proton pump inhibitors: a longitudinal observational cohort study of United States veterans
BMJ Open. 2017; 7, e015735
56.
Dial, S. ∙ Delaney, J.A.C. ∙ Barkun, A.N. ...
Use of gastric acid-suppressive agents and the risk of community-acquired Clostridium difficile-associated disease
JAMA. 2005; 294:2989-2995
57.
Leonard, J. ∙ Marshall, J.K. ∙ Moayyedi, P.
Systematic review of the risk of enteric infection in patients taking acid suppression
Am J Gastroenterol. 2007; 102:2047-2056
quiz 2057
reported various associations of PPI use with adverse events, raising questions for patients and providers regarding possible long-term consequences of PPI use. Furthermore, long-term PPI users may only be partially responsive, intolerant, or searching for better options than a PPI; therefore, PPI de-escalation and stewardship was discussed by the panel.
The panel recommended medical management, including PPIs at the lowest dose for the shortest period, while initiating discussions about long-term management options in patients with objectively confirmed GERD. The panel also provided best practice advice on the use of PPIs including discussion of risks and benefits before starting therapy, and consideration of de-escalation or dose optimization when symptoms are well controlled after PPIs have been used for >6 months. The panel discussed the lack of robust clinical evidence on CYP2C19; however, they also acknowledged the importance of CYP2C19 genotype data to guide PPI therapy. This incorporates patients who are not responding optimally to PPI therapy and who may benefit from a higher dose, in addition to those who benefit from changing to a PPI with an alternative metabolic pathway. Therefore, the panel agreed to a best practice advice suggesting assessment of CYP2C19 genotype and tailoring PPI therapy accordingly in patients with persistent and confirmed GERD who have failed to respond to standard medical therapy. The panel acknowledged existing H2 receptor blockers and their over-the-counter availability. Because the reviewed evidence demonstrated superiority of PPIs over H2 receptor blockers for GERD therapy, PPIs are favored for patients with erosive esophagitis and uncontrolled GERD with confirmed objective acid reflux study. At the same time, the panel agreed on the use of H2 receptor blockers as an adjunct, as-needed therapy and when faster onset of action might be required on a case-by-case basis.
The panel also discussed the newer potassium channel competitive acid blockers and their positioning in the GERD management. These agents were not readily available in North America at the time of evidence review and panel meeting. A recent RCT demonstrated effectiveness of vonoprazan over lansoprazole for healing and maintenance of healing of erosive esophagitis.
5858.
Laine, L. ∙ DeVault, K. ∙ Katz, P. ...
Vonoprazan versus lansoprazole for healing and maintenance of healing of erosive esophagitis: a randomized trial
Gastroenterology. 2023; 164:61-71
A recent systematic review and meta-analysis (19 studies, 7023 subjects) also showed that vonoprazan is superior to PPIs in first-line
Helicobacter pylori eradication and erosive esophagitis but noninferior in other gastric acid-related diseases.
5959.
Simadibrata, D.M. ∙ Syam, A.F. ∙ Lee, Y.Y.
A comparison of efficacy and safety of potassium-competitive acid blocker and proton pump inhibitor in gastric acid-related diseases: a systematic review and meta-analysis
J Gastroenterol Hepatol. 2022; 37:2217-2228
The panel agreed unanimously that existing data do not show superiority of potassium channel competitive acid blockers over PPIs overall for GERD but likely that potassium channel competitive acid blockers are more potent for erosive esophagitis and that their long-term adverse event data are not available. The panel, however, also agreed that with evolving data, potassium channel competitive acid blockers likely will be used for confirmed GERD patients with discussion of existing data and risks and benefits.
Summary of the evidence
We performed a systematic review of studies examining efficacy and safety of TIF compared with medical therapy with PPIs (and/or sham intervention) among patients with chronic GERD. Our results were limited to available therapies (existing TIF 2.0 [Esophyx 2.0, EndoGastric Solutions, Redmond, Wash, USA]) because prior versions are out of date. Our literature search identified 4 RCTs, 18 cohort studies, and 4 existing meta-analyses.
60-8560.
Trad, K.S. ∙ Barnes, W.E. ∙ Prevou, E.R. ...
The TEMPO trial at 5 years: transoral fundoplication (TIF 2.0) is safe, durable, and cost-effective
Surg Innov. 2018; 25:149-157
61.
Hunter, J.G. ∙ Kahrilas, P.J. ∙ Bell, R.C.W. ...
Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial
Gastroenterology. 2015; 148:324-333
62.
Witteman, B.P.L. ∙ Conchillo, J.M. ∙ Rinsma, N.F. ...
Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease
Am J Gastroenterol. 2015; 110:531-542
63.
Håkansson, B. ∙ Montgomery, M. ∙ Cadiere, G.B. ...
Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD
Aliment Pharmacol Ther. 2015; 42:1261-1270
64.
Richter, J.E. ∙ Kumar, A. ∙ Lipka, S. ...
Efficacy of laparoscopic Nissen fundoplication vs transoral incisionless fundoplication or proton pump inhibitors in patients with gastroesophageal reflux disease: a systematic review and network meta-analysis
Gastroenterology. 2018; 154:1298-1308
65.
Testoni, S. ∙ Hassan, C. ∙ Mazzoleni, G. ...
Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis
Endosc Int Open. 2021; 9:E239-E246
66.
Chandan, S. ∙ Mohan, B.P. ∙ Khan, S.R. ...
Clinical efficacy and safety of magnetic sphincter augmentation (MSA) and transoral incisionless fundoplication (TIF2) in refractory gastroesophageal reflux disease (GERD): a systematic review and meta-analysis
Endosc Int Open. 2021; 9:E583-E598
67.
Huang, X. ∙ Chen, S. ∙ Zhao, H. ...
Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis
Surg Endosc. 2017; 31:1032-1044
68.
Bell, R.C.W. ∙ Barnes, W.E. ∙ Carter, B.J. ...
Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study
Am Surg. 2014; 80:1093-1105
69.
Demyttenaere, S.V. ∙ Bergman, S. ∙ Pham, T. ...
Transoral incisionless fundoplication for gastroesophageal reflux disease in an unselected patient population
Surg Endosc. 2010; 24:854-858
70.
Frazzoni, M. ∙ Conigliaro, R. ∙ Manta, R. ...
Reflux parameters as modified by EsophyX or laparoscopic fundoplication in refractory GERD
Aliment Pharmacol Ther. 2011; 34:67-75
71.
Hoppo, T. ∙ Immanuel, A. ∙ Schuchert, M. ...
Transoral incisionless fundoplication 2.0 procedure using EsophyXTM for gastroesophageal reflux disease
J Gastrointest Surg. 2010; 14:1895-1901
72.
Muls, V. ∙ Eckardt, A.J. ∙ Marchese, M. ...
Three-year results of a multicenter prospective study of transoral incisionless fundoplication
Surg Innov. 2013; 20:321-330
73.
Petersen, B.T. ∙ Cohen, J. ∙ Hambrick, R.D. ...
Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update
Gastrointest Endosc. 2017; 85:282-294
74.
Rinsma, N.F. ∙ Smeets, F.G. ∙ Bruls, D.W. ...
Effect of transoral incisionless fundoplication on reflux mechanisms
Surg Endosc. 2014; 28:941-949
75.
Testoni, P.A. ∙ Testoni, S. ∙ Mazzoleni, G. ...
Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study
Surg Endosc. 2015; 29:2770-2780
76.
Toomey, P. ∙ Teta, A. ∙ Patel, K. ...
Transoral incisionless fundoplication: Is it as safe and efficacious as a Nissen or Toupet fundoplication?
Am Surg. 2014; 80:860-867
77.
Trad, K.S. ∙ Turgeon, D.G. ∙ Deljkich, E.
Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms
Surg Endosc. 2012; 26:650-660
78.
Velanovich, V.
Endoscopic, endoluminal fundoplication for gastroesophageal reflux disease: initial experience and lessons learned
Surgery. 2010; 148:646-653
79.
Wilson, E.B. ∙ Barnes, W.E. ∙ Mavrelis, P.G. ...
The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience
Surg Laparosc Endosc Percutan Tech. 2014; 24:36-46
80.
Stefanidis, G. ∙ Viazis, N. ∙ Kotsikoros, N. ...
Long-term benefit of transoral incisionless fundoplication using the Esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy
Dis Esoph. 2017; 30:1-8
81.
Narsule, C.K. ∙ Burch, M.A. ∙ Ebright, M.I. ...
Endoscopic fundoplication for the treatment of gastroesophageal reflux disease: initial experience
J Thorac Cardiovasc Surg. 2012; 143:228-234
82.
Barnes, W.E. ∙ Hoddinott, K.M. ∙ Mundy, S. ...
Transoral incisionless fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GERD in community practice
Surg Innov. 2011; 18:119-129
83.
Bell, R.C.W. ∙ Freeman, K.D.
Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease
Surg Endosc. 2011; 25:1975-1984
84.
Ihde, G.M. ∙ Besancon, K. ∙ Deljkich, E.
Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease
Am J Surg. 2011; 202:740-746
discussion 746-7
85.
Nguyen, A. ∙ Vo, T. ∙ Nguyen, X.M. ...
Transoral incisionless fundoplication: initial experience in patients referred to an integrated academic institution
Am Surg. 2011; 77:1386-1389
When compared with medical therapy with PPIs (and/or sham intervention), patients undergoing TIF 2.0 were more likely to stop their PPIs (77.6% vs 6.3%, 3 RCTs
6060.
Trad, K.S. ∙ Barnes, W.E. ∙ Prevou, E.R. ...
The TEMPO trial at 5 years: transoral fundoplication (TIF 2.0) is safe, durable, and cost-effective
Surg Innov. 2018; 25:149-157
62.
Witteman, B.P.L. ∙ Conchillo, J.M. ∙ Rinsma, N.F. ...
Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease
Am J Gastroenterol. 2015; 110:531-542
63.
Håkansson, B. ∙ Montgomery, M. ∙ Cadiere, G.B. ...
Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD
Aliment Pharmacol Ther. 2015; 42:1261-1270
; pooled risk ratio [RR], 12.7; 95% CI, 1.15-140.3;
I2 = 74%,
P = .04). Among 14 cohort studies
6868.
Bell, R.C.W. ∙ Barnes, W.E. ∙ Carter, B.J. ...
Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study
Am Surg. 2014; 80:1093-1105
69.
Demyttenaere, S.V. ∙ Bergman, S. ∙ Pham, T. ...
Transoral incisionless fundoplication for gastroesophageal reflux disease in an unselected patient population
Surg Endosc. 2010; 24:854-858
71.
Hoppo, T. ∙ Immanuel, A. ∙ Schuchert, M. ...
Transoral incisionless fundoplication 2.0 procedure using EsophyXTM for gastroesophageal reflux disease
J Gastrointest Surg. 2010; 14:1895-1901
72.
Muls, V. ∙ Eckardt, A.J. ∙ Marchese, M. ...
Three-year results of a multicenter prospective study of transoral incisionless fundoplication
Surg Innov. 2013; 20:321-330
73.
Petersen, B.T. ∙ Cohen, J. ∙ Hambrick, R.D. ...
Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update
Gastrointest Endosc. 2017; 85:282-294
74.
Rinsma, N.F. ∙ Smeets, F.G. ∙ Bruls, D.W. ...
Effect of transoral incisionless fundoplication on reflux mechanisms
Surg Endosc. 2014; 28:941-949
75.
Testoni, P.A. ∙ Testoni, S. ∙ Mazzoleni, G. ...
Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study
Surg Endosc. 2015; 29:2770-2780
77.
Trad, K.S. ∙ Turgeon, D.G. ∙ Deljkich, E.
Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms
Surg Endosc. 2012; 26:650-660
79.
Wilson, E.B. ∙ Barnes, W.E. ∙ Mavrelis, P.G. ...
The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience
Surg Laparosc Endosc Percutan Tech. 2014; 24:36-46
80.
Stefanidis, G. ∙ Viazis, N. ∙ Kotsikoros, N. ...
Long-term benefit of transoral incisionless fundoplication using the Esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy
Dis Esoph. 2017; 30:1-8
82.
Barnes, W.E. ∙ Hoddinott, K.M. ∙ Mundy, S. ...
Transoral incisionless fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GERD in community practice
Surg Innov. 2011; 18:119-129
83.
Bell, R.C.W. ∙ Freeman, K.D.
Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease
Surg Endosc. 2011; 25:1975-1984
84.
Ihde, G.M. ∙ Besancon, K. ∙ Deljkich, E.
Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease
Am J Surg. 2011; 202:740-746
discussion 746-7
85.
Nguyen, A. ∙ Vo, T. ∙ Nguyen, X.M. ...
Transoral incisionless fundoplication: initial experience in patients referred to an integrated academic institution
Am Surg. 2011; 77:1386-1389
, only 28% of patients were taking PPIs at a mean follow-up of 19.1 months after TIF 2.0 compared with baseline (98.8%; pooled RR, 2.93; 95% CI, 2.06-4.15;
I2 = 90%,
P < .01). Additionally, one-third of patients were completely off PPIs at long-term follow-up of 8 to 10 years (2 observational studies,
7575.
Testoni, P.A. ∙ Testoni, S. ∙ Mazzoleni, G. ...
Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study
Surg Endosc. 2015; 29:2770-2780
123.
Chimukangara, M. ∙ Jalilvand, A.D. ∙ Melvin, W.S. ...
Long-term reported outcomes of transoral incisionless fundoplication: an 8-year cohort study
Surg Endosc. 2019; 33:1304-1309
34.4% [37/107]).
When compared with a sham intervention, acid exposure time was significantly lower among patients undergoing TIF 2.0 (2 RCTs; mean difference [MD], –2.38; 95% CI, –4.54 to –.22; I2 = 37%, P = .03). Normalization of acid exposure time was nonsignificantly higher among patients undergoing TIF 2.0 compared with medical therapy and/or sham intervention (2 RCTs; RR, 1.62; 95% CI, .3-8.62; I2 = 90%, P = .57).
Patients undergoing TIF 2.0 compared with medical therapy and/or sham intervention had a higher rate of GERD symptom resolution after TIF 2.0 compared with the PPI-sham group at a mean 6 months of follow-up (4 RCTs, 68.2% vs 32.4%; pooled RR, 2.12; 95% CI, 1.27-3.54; I2 = 57%, P < .01). However, the definition of success varied between studies.
When evaluating the overall adverse event rate from the existing RCTs, the rate was higher after TIF 2.0 compared with medical therapy (and/or sham) (4 RCTs, 37.8% vs 14.3%; pooled RR, 2.56; 95% CI, 1.36-4.81;
I2 = 0%,
P < .01). However, the rate of significant and serious adverse events was not statistically significantly different between TIF 2.0 and medical therapy (and/or sham) (4 RCTs, 8% for TIF vs 1.9% for medical therapy; pooled RR, 2.94; 95% CI, .94-9.19;
I2 = 0%,
P < .01). We also reviewed postmarketing surveillance data from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience on TIF reporting 95 events and 131 patient adverse events of which perforation (19.8%), pleural effusion (9.2%), and bleeding (9.2%) were the most common among reported adverse events. Most of these adverse events were managed endoscopically.
8686.
Ramai, D. ∙ Shapiro, A. ∙ Barakat, M. ...
Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis
Surg Endosc. 2022; 36:4956-4959
When evaluating the severe adverse event rate from RCTs and prospective studies combined, the rate was even lower at 2.4% for TIF (4 RCTs and 12 prospective studies, 19/781). Furthermore, the rate of perforation was .9% (7/781), of post-TIF bleeding was .65% (5/781), and of pneumothorax was .5% (4/781). There was 1 death among 781 TIF 2.0 procedures, which occurred 20 months later from an unrelated cause. When evaluating post-TIF dysphagia, the pooled rate was 3.6% among 9 cohort studies (95% CI, 1.4-8.8; I2 = 58%, P = .05).
Regarding cost-analysis, TIF 2.0 ($13,978.63) had lower direct costs compared with laparoscopic Nissen fundoplication ($17,658.47) but more than PPIs (omeprazole 20 mg twice daily, $10,931.49).
8787.
McCarty, T.R. ∙ Jirapinyo, P. ∙ James, L.P. ...
Transoral incisionless fundoplication is cost-effective for treatment of gastroesophageal reflux disease
Endosc Int Open. 2022; 10:E923-E932
Compared with the PPI strategy, TIF was cost-effective, with an incremental cost of $3047 and incremental effectiveness of .29 quality-adjusted life-years. In a subgroup of patients with resource utilization in the top quartile (ie, PPI-refractory GERD), the average cost of care over 2 years was much lower with TIF 2.0 compared with laparoscopic Nissen fundoplication ($66,000 vs $124,000).
When assessing patient values, there were no available data. Our patient advocate acknowledged that having a minimally invasive option is preferable to patients.
Overall, the certainty in the evidence was moderate to very low. The panel acknowledged that available evidence has varying patient populations and varying definitions of outcomes among these studies. However, overall TIF 2.0 showed short-term improvement with durable symptom remission up to 5 years with relatively low serious adverse event rates. The panel discussed the role of TIF 2.0 for a subset of the population, which included patients with chronic GERD symptoms for at least 6 months, those with refractory GERD (defined as the presence of persistent troublesome GERD symptoms despite PPI optimization [double-dose PPI therapy over ≥8 weeks] in the setting of ongoing documented pathologic reflux
8888.
Yadlapati, R. ∙ DeLay, K.
PPI refractory gastroesophageal reflux disease
Med Clin North Am. 2019; 103:15-27
), those with regurgitation-predominant symptoms,
6060.
Trad, K.S. ∙ Barnes, W.E. ∙ Prevou, E.R. ...
The TEMPO trial at 5 years: transoral fundoplication (TIF 2.0) is safe, durable, and cost-effective
Surg Innov. 2018; 25:149-157
those with PPI intolerance or wanting to stop taking PPIs, and patients with Hill grades I or II and hiatal hernia <2 cm.
Summary of the evidence
We performed a systematic review of studies examining efficacy and safety of cTIF compared with medical therapy with PPIs (and/or sham intervention) among patients with chronic GERD with a large hiatal hernia. Outcomes of interest were PPI discontinuation, reduction in acid exposure time (% time pH < 4), normalization of esophageal acid exposure time (per patient), symptom resolution (per patient), durable symptom resolution, GERD score improvement (GERD health-related quality of life scores or similar scales), and adverse events (including severe adverse events and post-TIF dysphagia).
Seven cohort studies met selection criteria for inclusion.
8484.
Ihde, G.M. ∙ Besancon, K. ∙ Deljkich, E.
Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease
Am J Surg. 2011; 202:740-746
discussion 746-7
89.
Janu, P. ∙ Shughoury, A.B. ∙ Venkat, K. ...
Laparoscopic hiatal hernia repair followed by transoral incisionless fundoplication with EsophyX device (HH + TIF): efficacy and safety in two community hospitals
Surg Innov. 2019; 26:675-686
90.
Jaruvongvanich, V.K. ∙ Matar, R. ∙ Reisenauer, J. ...
Hiatal hernia repair with transoral incisionless fundoplication versus Nissen fundoplication for gastroesophageal reflux disease: a retrospective study
Endosc Int Open. 2023; 11:E11-E18
91.
Snow, G.E. ∙ Dbouk, M. ∙ Akst, L.M. ...
Response of laryngopharyngeal symptoms to transoral incisionless fundoplication in patients with refractory proven gastroesophageal reflux
Ann Otol Rhinol Laryngol. 2022; 131:662-670
92.
Gisi, C. ∙ Wang, K. ∙ Khan, F. ...
Efficacy and patient satisfaction of single-session transoral incisionless fundoplication and laparoscopic hernia repair
Surg Endosc. 2021; 35:921-927
93.
Choi, A.Y. ∙ Roccato, M.K. ∙ Samarasena, J.B. ...
Novel interdisciplinary approach to GERD: concomitant laparoscopic hiatal hernia repair with transoral incisionless fundoplication
J Am Coll Surg. 2021; 232:309-318
94.
Ihde, 2nd, G.M. ∙ Pena, C. ∙ Scitern, C. ...
pH scores in hiatal repair with transoral incisionless fundoplication
JSLS. 2019; 23
e2018.00087
Our literature search also identified an ongoing multicenter RCT (clinical trials identifier: NCT04795934). On meta-analysis, cTIF was associated with a lower use of PPIs compared with use before the procedure (37.5% vs 94.6%; pooled OR, .71; 95% CI, .48-.93,
I2 = 94%,
P < .01). cTIF was also associated with better symptom resolution compared with preintervention values (pooled MD, 21.87; 95% CI, 12.91-29.83;
I2 = 100%,
P < .01). Among 358 patients undergoing cTIF, only 2 (.01%) had serious adverse events. The rate of dysphagia was also low at .06% (7/125) after cTIF per 1 cohort study.
9090.
Jaruvongvanich, V.K. ∙ Matar, R. ∙ Reisenauer, J. ...
Hiatal hernia repair with transoral incisionless fundoplication versus Nissen fundoplication for gastroesophageal reflux disease: a retrospective study
Endosc Int Open. 2023; 11:E11-E18
Objective outcomes for GERD assessment were inconsistently reported by available studies, and therefore a pooled analysis was not performed. No studies reported long-term symptom resolution, patient values and preferences, or cost-effectiveness data.
Overall, the certainty of the evidence was very low. The panel considered the evidence as important but inadequate because of initial data with small-size studies. The panel also discussed that cTIF could serve as an alternative to existing surgical therapies or as an additional treatment option. Evidence for surgical therapies have been established and whether cTIF is comparable is not yet established with high-quality data. The panel made a conditional recommendation suggesting cTIF or other surgical intervention based on multidisciplinary review for patients with confirmed GERD and a large hiatal hernia (>2 cm) and Hill grade III/IV.
Summary of the evidence
We performed a systematic review of studies examining efficacy and safety of radiofrequency energy to the lower esophageal sphincter (Stretta, Restech Reflux Solutions, Houston, Tex, USA) compared with medical therapy with PPIs (and/or sham intervention) among patients with chronic GERD. Our literature search identified 5 eligible RCTs and 1 existing meta-analysis.
95-10095.
Arts, J. ∙ Bisschops, R. ∙ Blondeau, K. ...
A double-blind sham-controlled study of the effect of radiofrequency energy on symptoms and distensibility of the gastro-esophageal junction in GERD
Am J Gastroenterol. 2012; 107:222-230
96.
Aziz, A.M.A. ∙ El-Khayat, H.R. ∙ Sadek, A. ...
A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease
Surg Endosc. 2010; 24:818-825
97.
Corley, D.A. ∙ Katz, P. ∙ Wo, J.M. ...
Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial
Gastroenterology. 2003; 125:668-676
98.
Coron, E. ∙ Sebille, V. ∙ Cadiot, G. ...
Clinical trial: radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients
Aliment Pharmacol Ther. 2008; 28:1147-1158
99.
Kalapala, R. ∙ Shah, H. ∙ Nabi, Z. ...
Treatment of gastroesophageal reflux disease using radiofrequency ablation (Stretta procedure): an interim analysis of a randomized trial
Indian J Gastroenterol. 2017; 36:337-342
100.
Fass, R. ∙ Cahn, F. ∙ Scotti, D.J. ...
Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease
Surg Endosc. 2017; 31:4865-4882
When compared with medical therapy with PPI (and/or sham intervention), patients undergoing Stretta were able to stop the PPI therapy at a higher rate (28.7% vs 12.7%), but the difference was not statistically significant (4 RCTs; pooled RR, 3.93; 95% CI, .8-19.38;
I2 = 44,
P = .09).
96-9996.
Aziz, A.M.A. ∙ El-Khayat, H.R. ∙ Sadek, A. ...
A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease
Surg Endosc. 2010; 24:818-825
97.
Corley, D.A. ∙ Katz, P. ∙ Wo, J.M. ...
Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial
Gastroenterology. 2003; 125:668-676
98.
Coron, E. ∙ Sebille, V. ∙ Cadiot, G. ...
Clinical trial: radiofrequency energy delivery in proton pump inhibitor-dependent gastro-oesophageal reflux disease patients
Aliment Pharmacol Ther. 2008; 28:1147-1158
99.
Kalapala, R. ∙ Shah, H. ∙ Nabi, Z. ...
Treatment of gastroesophageal reflux disease using radiofrequency ablation (Stretta procedure): an interim analysis of a randomized trial
Indian J Gastroenterol. 2017; 36:337-342
When data from 23 cohort studies were examined, half of the patients were able to stop the PPI after Stretta compared with baseline (PPI use decreased from 97.1% to 47.4%; pooled RR, .49; 95% CI, .4-.6;
I2 = 95%,
P < .01).
100100.
Fass, R. ∙ Cahn, F. ∙ Scotti, D.J. ...
Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease
Surg Endosc. 2017; 31:4865-4882
When compared with medical therapy with PPIs (and/or sham intervention), symptom resolution (defined as GERD symptoms <3 per week and GERD health-related quality of life score ≤11 at 12 months) was not significantly different after Stretta (40.6% Stretta vs 30.8% PPI; 2 RCTs; pooled RR, 1.35; 95% CI, .3-6.06;
I2 = 14%,
P = .69). When compared with medical therapy with PPIs (and/or sham intervention), GERD health-related quality of life scores were lower after Stretta in observational studies, but the results were not significant when evaluating RCTs only (2 RCTs; pooled MD, –3.99; 95% CI, –17.11 to 9.13;
I2 = 91%,
P = .55) and 11 observational studies
100100.
Fass, R. ∙ Cahn, F. ∙ Scotti, D.J. ...
Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease
Surg Endosc. 2017; 31:4865-4882
(pooled MD, –14.6; 95% CI, –12.73 to –16.48;
I2 = 82%,
P < .01).
Acid exposure time was not significantly different after Stretta compared with the PPI-sham group among 3 RCTs (pooled MD, –.22; 95% CI, –2.52 to 2.07;
I2 = 41%,
P = .85). However, acid exposure time was significantly lower after Stretta compared with baseline values among the same patients in 14 cohort studies (pooled MD, –3.01; 95% CI, –3.72 to –2.3;
I 22.
El-Serag, H.B. ∙ Sweet, S. ∙ Winchester, C.C. ...
Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review
Gut. 2014; 63:871-880
=35%,
P < .01).
100100.
Fass, R. ∙ Cahn, F. ∙ Scotti, D.J. ...
Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease
Surg Endosc. 2017; 31:4865-4882
Normalization of esophageal acid exposure was not significantly different among patients undergoing Stretta compared with PPIs and/or sham (17.1% vs 10.7%; pooled RR, 1.84; 95% CI, .02-144.06;
I2 = 81%,
P = .78). Among 8 cohort studies, 30% of patients (43/144) had normalization of acid exposure time after Stretta compared with baseline.
100100.
Fass, R. ∙ Cahn, F. ∙ Scotti, D.J. ...
Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease
Surg Endosc. 2017; 31:4865-4882
When compared with medical therapy with PPIs (and/or sham intervention), the adverse event rate was higher among the Stretta group (4 RCTs, 42% vs 11.1%; pooled RR, 3.06; 95% CI, 1.09-8.6; I
2 = 5%,
P < .01). However, when data on overall adverse events were examined from cohort studies and RCTs (n = 26), the adverse event rate was .9% (23/2468) after Stretta compared with 1.4% after PPIs and/or sham treatment (1/72 [
P value not available]).
100100.
Fass, R. ∙ Cahn, F. ∙ Scotti, D.J. ...
Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease
Surg Endosc. 2017; 31:4865-4882
When compared with medical therapy with PPIs (and/or sham intervention), the serious or severe adverse event rate was not significantly different after Stretta versus PPIs (3.7% vs 1.4%; pooled RR, 1.9; 95% CI, .26-14.06; I
2 = 0%,
P = .53). When severe or serious adverse events were examined from RCTs and cohort studies (n = 26), it was .3% (7/2468) after Stretta compared with 1.9% after PPIs and/or sham intervention (1/52 [
P value not available]).
100100.
Fass, R. ∙ Cahn, F. ∙ Scotti, D.J. ...
Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease
Surg Endosc. 2017; 31:4865-4882
No direct cost-effectiveness study was found. When examining patient values, we relied on our patient advocate, who preferred having a minimally invasive option for durable symptom relief compared with lifelong medical therapy with potential side effects.
Overall, the certainty in the evidence was low to very low. The panel acknowledged that evidence on Stretta has been affected by differing results from RCTs and cohort studies and existing challenges including lack of durable benefit, no effect on PPIs, no effect on acid exposure, higher adverse events, better available treatments, and reimbursement concerns. Stretta is only applicable for GERD patients with small hiatal hernias (≤2 cm) and Hill grade I or II.
Other Considerations
Endoscopic therapies in pediatric patients
A literature search was performed to evaluate the current use of endoscopic antireflux therapies in pediatric patients. Four case series with a small number of patients were found.
101-104101.
Chen, S. ∙ Jarboe, M.D. ∙ Teitelbaum, D.H.
Effectiveness of a transluminal endoscopic fundoplication for the treatment of pediatric gastroesophageal reflux disease
Pediatr Surg Int. 2012; 28:229-234
102.
Robertson, J.O. ∙ Jarboe, M.D.
Long-term outcomes of transoral incisionless fundoplication in a high-risk pediatric population
J Laparoendosc Adv Surg Tech A. 2018; 28:95-100
103.
Fanous, M. ∙ Jaehne, A. ∙ Simbob, J.
The benefits of nonablative radiofrequency treatment of the lower esophageal sphincter after transoral incisionless fundoplication
Am Surg. 2020; 86:1525-1527
104.
Liu, D.C. ∙ Somme, S. ∙ Mavrelis, P.G. ...
Stretta as the initial antireflux procedure in children
J Pediatr Surg. 2005; 40:148-151
discussion 151-2
Two studies
101101.
Chen, S. ∙ Jarboe, M.D. ∙ Teitelbaum, D.H.
Effectiveness of a transluminal endoscopic fundoplication for the treatment of pediatric gastroesophageal reflux disease
Pediatr Surg Int. 2012; 28:229-234
102.
Robertson, J.O. ∙ Jarboe, M.D.
Long-term outcomes of transoral incisionless fundoplication in a high-risk pediatric population
J Laparoendosc Adv Surg Tech A. 2018; 28:95-100
reported the use of TIF, and 2
102,103 examined Stretta for pediatric patients. These small studies demonstrate that Stretta can be used in pediatric patients. TIF seemed to demonstrate improved results in children, with 10 of 11 patients in 1 study having resolution of GERD
101101.
Chen, S. ∙ Jarboe, M.D. ∙ Teitelbaum, D.H.
Effectiveness of a transluminal endoscopic fundoplication for the treatment of pediatric gastroesophageal reflux disease
Pediatr Surg Int. 2012; 28:229-234
and 8 of 10 patients in another study
102102.
Robertson, J.O. ∙ Jarboe, M.D.
Long-term outcomes of transoral incisionless fundoplication in a high-risk pediatric population
J Laparoendosc Adv Surg Tech A. 2018; 28:95-100
able to discontinue PPIs.
The pediatrics population has a wide age range, and the size of the scope with the device could pose a significant challenge and adverse events. Therefore, endoscopic antireflux therapies should currently only be performed in pediatric patients in the setting of a well-designed research study.
Novel GERD therapies
We performed a systematic review of studies comparing emerging and novel antireflux endoscopic interventions with medical therapy and/or sham interventions among adult (age ≥18 years) patients with chronic GERD. The novel and/or emerging interventions in this field include EMR (using band ligation or other forms of resection with or without plication), endoscopic mucosal ablation (using hybrid argon plasma coagulation or similar), an ultrasonic surgical endostapler device (MUSE; Medigus, Omer, Israel), and plication-based therapies including GERDx (G-SURG GmbH, Seeon-Seebruck, Germany). We also excluded interventions if the technology was out of date, not available, or has not been examined as a part of a clinical trial.
Our systematic review identified 1 RCT
105105.
Kalapala, R. ∙ Karyampudi, A. ∙ Nabi, Z. ...
Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial
Gut. 2022; 71:686-694
and 1 prospective cohort study
106106.
Weitzendorfer, M. ∙ Spaun, G.O. ∙ Antoniou, S.A. ...
Clinical feasibility of a new full-thickness endoscopic plication device (GERDxTM) for patients with GERD: results of a prospective trial
Surg Endosc. 2018; 32:2541-2549
examining endoscopic full-thickness fundoplication using a novel GERDx device, 7 prospective cohort noncomparative studies of the MUSE device,
107-113107.
Roy-Shapira, A. ∙ Bapaye, A. ∙ Date, S. ...
Trans-oral anterior fundoplication: 5-year follow-up of pilot study
Surg Endosc. 2015; 29:3717-3721
108.
Zacherl, J. ∙ Roy-Shapira, A. ∙ Bonavina, L. ...
Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSETM) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial
Surg Endosc. 2015; 29:220-229
109.
Kim, H.J. ∙ Kwon, C.I. ∙ Kessler, W.R. ...
Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSETM endoscopic stapling device
Surg Endosc. 2016; 30:3402-3408
110.
Peng, L. ∙ Wan, R. ∙ Chen, S. ...
Efficacy of endoscopic anterior fundoplication with a novel ultrasonic surgical endostapler for gastroesophageal reflux disease: six-month results from a multicenter prospective trial
Endosc Ultrasound. 2023; 12:128
111.
Testoni, S.G.G. ∙ Cilona, M.B. ∙ Mazzoleni, G. ...
Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years
Surg Endosc. 2022; 36:5023-5031
112.
Testoni, P.A. ∙ Testoni, S. ∙ Mazzoleni, G. ...
Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes
Endoscopy. 2020; 52:469-473
113.
Shen, S. ∙ Yu, G. ∙ Guo, X. ...
The long-term efficacy of transoral incisionless fundoplication with Medigus Ultrasonic Surgical Endostapler (MUSE) for gastroesophageal reflux disease
Esophagus. 2023; 20:581-586
1 meta-analysis examining 10 noncontrolled cohort studies of antireflux mucosectomy,
114114.
Garg, R. ∙ Mohammed, A. ∙ Singh, A. ...
Anti-reflux mucosectomy for refractory gastroesophageal reflux disease: a systematic review and meta-analysis
Endosc Int Open. 2022; 10:E854-E864
1 nonrandomized comparative study for clip-band ligation antireflux therapy,
115115.
Liu, S. ∙ Chai, N. ∙ Zhai, Y. ...
New treatment method for refractory gastroesophageal reflux disease (GERD): C-BLART (clip band ligation anti-reflux therapy)-a short-term study
Surg Endosc. 2020; 34:4516-4524
1 comparative trial of band ligation alone,
116116.
Seleem, W.M. ∙ Hanafy, A.S. ∙ Mohamed, S.I.
Endoscopic management of refractory gastroesophageal reflux disease
Scand J Gastroenterol. 2018; 53:390-397
3 noncontrolled cohort studies of the resection and plication method,
117-119117.
Randhawa, N. ∙ Khalyfa, A. ∙ Khan, M. ...
Utilization of antireflux mucosectomy and resection and plication: a novel approach for the management of recurrent gastroesophageal reflux disease after prior Nissen fundoplication or transoral incisionless fundoplication
J Clin Med. 2022; 11:7141
118.
Benias, P.C. ∙ D’Souza, L. ∙ Lan, G. ...
Initial experience with a novel resection and plication (RAP) method for acid reflux: a pilot study
Endosc Int Open. 2018; 6:E443-E449
119.
Walsh, P.R. ∙ Lamba, M. ∙ Benias, P. ...
Feasibility of resection and plication “RAP” technique for management of medically refractory GERD in patients with altered gastric anatomy
Endosc Int Open. 2021; 9:E1549-E1555
and 1 meta-analysis examining 3 nonrandomized studies of antireflux mucosal ablation
120-122120.
Mondragón, O.V.H. ∙ Mottú, R.A.Z. ∙ Contreras, L.F.G. ...
Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video)
Gastrointest Endosc. 2020; 92:1190-1201
121.
Inoue, H. ∙ Tanabe, M. ∙ de Santiago, E.R. ...
Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study
Endosc Int Open. 2020; 8:E133-E138
122.
Rodríguez de Santiago, E. ∙ Sanchez-Vegazo, C.T. ∙ Peñas, B. ...
Antireflux mucosectomy (ARMS) and antireflux mucosal ablation (ARMA) for gastroesophageal reflux disease: a systematic review and meta-analysis
Endosc Int Open. 2021; 9:E1740-E1751
as an antireflux intervention among patients with chronic GERD. We also found an RCT examining antireflux mucosectomy (clinical trials identifier: NCT04194723) and 2 RCTs examining antireflux mucosal ablation (clinical trials identifier: NCT04711655 and NCT05570448) that are underway.
Overall, short-term follow-up among these studies demonstrated improvement in GERD symptoms or related scores with a minimal adverse event profile. Similar to TIF 2.0, these strategies are primarily used for patients with chronic objectively confirmed GERD with small hiatal hernias. Robust data demonstrating a durable benefit of any 1 of these compared with standard medical therapy are lacking. We did not find any of these technologies being compared with TIF 2.0 in an RCT design. The panel recognized the promise of these emerging technologies that may become more prevalent as more data become available.
Future Directions
This guideline and literature review highlighted several areas in need of more data to guide decision-making for managing chronic GERD. Future studies should address the following:
1.
Long-term benefit: Existing medical, endoscopic, and surgical therapies, despite a large body of evidence, do not have established evidence for long-term (>10 years) benefit. Previous studies of endoscopic antireflux therapies have demonstrated short-term benefit for a subset of patients. Future studies should examine long-term outcomes from endoscopic antireflux therapies including subjective and objective improvement in GERD with cessation of long-term PPI use. Similarly, these therapies need to be examined in comparison with medication adjustment and surgical therapies for best outcomes. Development of better endoscopic therapies that provide durable alteration of the antireflux barrier without need for surgery is required.
2.
Objective improvement in GERD: A large body of data on endoscopic antireflux therapies report subjective improvement in GERD; however, they lack consistent reporting of improvement in objective parameters of GERD including acid exposure time. Because of this, reliability and repeatability of these interventions remain a concern. Future studies should incorporate and examine objective improvements in GERD in addition to reliance on patient-reported outcomes, which could be subjective.
3.
Atypical GERD: Data on the benefit of medical therapy for atypical GERD symptoms are not robust. Improvement of atypical GERD symptoms (cough, reflux laryngitis, sore throat, asthma, throat clearing) should also be assessed in endoscopic antireflux therapies in a well-defined cohort. Additionally, existing therapies need to be examined for special populations where options are limited (ie, after SG, after POEM, scleroderma patients, etc).
4.
Incidence of GERD after POEM: Varying rates and evolving techniques have been reported over the years, making a precise assessment difficult. Recent studies report a low incidence of severe persistent esophagitis after POEM.
2323.
Vespa, E. ∙ Pellegatta, G. ∙ Chandrasekar, V.T. ...
Long-term outcomes of peroral endoscopic myotomy for achalasia: a systematic review and meta-analysis
Endoscopy. 2023; 55:167-175
It is unclear if there is an increased or decreased risk of BE and related esophageal cancer after POEM (ie, squamous cell and adenocarcinoma). Further studies are needed to better quantify these trends.
What Is New
These guidelines highlight data suggesting that upper endoscopy should be performed among patients with a history of SG to screen for BE and to evaluate for objective signs of GERD. These guidelines also suggest endoscopic therapy as an alternative for management of patients with chronic confirmed GERD. We have also provided a GERD management algorithm based on evidence and guidance from this document (
Fig. 1).
Guideline Update
ASGE guidelines are reviewed for updates approximately every 5 years or in the event that new data may influence a recommendation. Updates follow the same ASGE guideline development process.
Disclosure
The following authors disclosed financial relationships: N. C. Thosani: Consultant for Pentax of America, Inc, Boston Scientific Corporation, and Ambu Inc; travel compensation and food and beverage compensation from Pentax of America, Inc, Boston Scientific Corporation, and AbbVie Inc; speaker for AbbVie Inc. A. Saeed: Consultant for Endogastric Solutions, Medtronic, Boston Scientific Corporation, and Olympus. B. Abu Dayyeh: Consultant for Endogenex, Endo-TAGSS, Metamodix, BFKW, USGI, Apollo Endosurgery, Spatz Medical, Aspire Bariatrics, and Boston Scientific; research support from USGI, Apollo Endosurgery, Spatz Medical, Aspire Bariatrics, Boston Scientific, Medtronic, Endogastric Solutions, and Erbe Medical; speaker for Olympus, Johnson and Johnson, Medtronic, and Endogastric Solutions. M. I. Canto: Research support from Endogastric Solutions and Pentax Medical Corporation; consultant for Cernostics and ClearNote Health; scientific advisory board for Cernostics; royalties from UpToDate. W. Abidi: Consultant for Ambu Inc, Apollo Endosurgery US Inc, and Conmed Corporation; food and beverage compensation from Ambu Inc, Apollo Endosurgery US Inc, Conmed Corporation, Olympus America Inc, AbbVie Inc, Boston Scientific Corporation, RedHill Biopharma Inc, and Salix Pharmaceuticals; research support from GI Dynamics. S. K. Amateau: Consultant for Boston Scientific Corporation, Merit Medical, Olympus Corporation of the Americas, MTEndoscopy, US Endoscopy, Heraeus Medical Components, LLC, and Cook Medical LLC; travel compensation from Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation, Olympus Corporation of the Americas, and Cook Medical LLC; advisory board for Merit Medical. N. Cosgrove: Consultant for Olympus Corporation of the Americas and Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation and Ambu Inc. S. E. Elhanafi: Food and beverage compensation from Medtronic, Inc, Nestle HealthCare Nutrition Inc, Ambu Inc, Salix Pharmaceuticals, Takeda Pharmaceuticals USA, Inc, and Merit Medical Systems Inc. N. Forbes: Consultant for Boston Scientific Corporation and Pentax of America, Inc; speaker for Pentax of America, Inc and Boston Scientific Corporation; research support from Pentax of America, Inc. D. R. Kohli: Consultant for Olympus Corporation of the Americas; research support from Olympus Corporation of the Americas. L. L. Fujii-Lau: Consultant for Boston Scientific Corporation; food and beverage compensation from Pfizer Inc and AbbVie Inc. J. D. Machicado: Consultant for Mauna Kea Technologies, Inc; food and beverage compensation from Mauna Kea Technologies, Inc and Boston Scientific Corporation. N. B. Marya: Consultant for Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation and Apollo Endosurgery US Inc. S. Ngamruengphong: Consultant for Boston Scientific Corporation, Olympus, and Neptune Medical; food and beverage compensation from Medtronic, Inc, Boston Scientific Corporation, Pentax of America, Inc, and Ambu Inc. S. Pawa: Consultant for Boston Scientific Corporation. N. R. Thiruvengadam: Research support from Boston Scientific Corporation. B. J. Qumseya: Consultant for Medtronic, Inc and Assertio Management, LLC; food and beverage compensation from Medtronic, Inc, Fujifilm Healthcare Americas Corporation, and Boston Scientific Corporation; speaker for Castle Biosciences. All other authors disclosed no financial relationships.
Acknowledgments
We are grateful to Philip Daiza, a patient representative from the International Foundation for Gastrointestinal Disorders, for participating in our panel and to Robyn Rosasco (librarian) for assistance with searching for articles. We also thank Drs Luis Lara, Dennis Jensen, and Nalini Guda on behalf of the GIE Editorial Board and ASGE Governing Board for their review of the guidelines. This guideline was funded exclusively by the ASGE; no outside funding was received to support the development of this guideline.