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DOWNERS GROVE, Ill. – The September issue of GIE: Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the American Society for Gastrointestinal Endoscopy, features several studies about medications and treatments for gastrointestinal procedures and conditions. One article study looked at the use of a new procedure to treat esophageal cancer patients who have difficulty swallowing, and another evaluated the safety and effectiveness of a new sedation medication for colonoscopy.
Cryotherapy Beneficial for Dysphagia Patients With Inoperable Esophageal Cancer
Liquid nitrogen spray cryotherapy is safe and effective for improving dysphagia in patients with inoperable esophageal cancer, according to a new study published in the September issue of GIE: Gastrointestinal Endoscopy.
Liquid nitrogen spray cryotherapy is used to “freeze” the esophageal tumor, improving dysphagia, which affects the ability to swallow. This condition can contribute to poor quality of life and inadequate nutrition. The most common treatments for dysphagia are radiation therapy and stent placement in the esophagus. However, these treatments are associated with adverse events.
The retrospective, multicenter study, “Liquid nitrogen spray cryotherapy for dysphagia palliation in patients with inoperable esophageal cancer,” included 49 patients, most of whom received one to three cryotherapy treatments.
Prior to the cryotherapy treatment, patients were given a dysphagia score, ranging from 0 – no dysphagia – to 4 – difficulty swallowing their own saliva. Only four patients had a score of 0 or 1 – difficulty swallowing solids – before the treatment, but 20 patients scored 0 or 1 after the cryotherapy. In addition, the mean dysphagia score for all the patients improved from 2.4 to 1.7.
Of 113 total cryotherapy treatments, three of the dysphagia cases worsened by one point, 43 showed no change and 69 improved between one and three points.
The study also suggested that age at first cryotherapy and prior local treatment affected outcomes. Patients under the age of 60 appeared to have a .40-point greater improvement in dysphagia compared with patients aged 60 or older. In addition, patients with no prior local treatment had a .30-point greater improvement than patients who had previous local treatment.
While researchers concluded that cryotherapy is safe and effective for this patient population, they indicated that large prospective studies are needed to confirm the findings and determine the greatest patient and procedure benefits.
Clinical Trial Examines Safety and Effectiveness of Medication for Colonoscopy Sedation
A new study published in the September issue of GIE: Gastrointestinal Endoscopy reports that patients administered remimazolam, an ultrashort-acting benzodiazepine, for colonoscopy sedation have quicker neuropsychiatric function recovery, are ready for discharge earlier and feel “normal” sooner after the procedure than patients who receive a placebo or midazolam.
The study, “A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy,” included 461 patients at 12 U.S. sites. Each patient received 50 to 75 mg of fentanyl followed by a sedation medication, administered under the supervision of endoscopists. Patients were randomly assigned to receive remimazolam or placebo in a blinded manner or open-label midazolam, dispensed according to its package insert. If sedation was not achieved, midazolam was used as a “rescue” medication to complete the colonoscopy.
Sedation was considered successful if the following criteria were met: 1) the colonoscopy was completed; 2) rescue medication was not required; and 3) no more than five doses of remimazolam or placebo were administered in any 15-minute interval or no more than three doses of midazolam in a 12-minute interval.
The mean dose of remimazolam was 10.5 mg, which included the initial dose of 5 mg and two follow-up doses.
According to the study, 91.3% of the remimazolam recipients had a successful procedure compared to 1.7% of the placebo patients and 25.2% of the midazolam patients. Remimazolam patients also received less fentanyl and were less likely to experience hypotension than the other patients. In addition, there were no adverse events associated with remimazolam.
The researchers concluded that remimazolam is a safe option for outpatient colonoscopy.