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In Gut, we read a welcome report of the first randomised, sham-controlled, pilot clinical trial of endoscopic pyloromyotomy in 41 patients for the treatment of severe and refractory gastroparesis,1 documenting for the first time the efficacy of G-POEM compared with sham control with procedures performed under general anaesthesia. Success was determined by a 50% reduction in total Gastroparesis Cardinal Symptom Index (GCSI) score. Additional analyses assessed association of efficacy with change in gastric emptying (using 200 kcal, 2% fat egg-substitute meal) and EndoFLIP measurements of pylorus. The trial is appropriately labelled as a pilot, since a prespecified interim analysis after 40% randomisation led the data safety monitoring board to recommend stopping the trial because of greater efficacy with G-POEM compared with sham treatment, considering risks of general anaesthesia in patients undergoing the sham procedure. The 6-month treatment pilot trial concluded that, in the 41 patients (17 diabetic, 13 postsurgical (12 post fundoplication) and 11 idiopathic), G-POEM was superior to the sham procedure for improving both symptoms and gastric emptying, though the sample was too small to provide conclusive evidence of efficacy in idiopathic and postsurgical groups (see figure 2B from the original paper1). GCSI subscores suggest that the main differences in symptom outcome were for postprandial fullness and bloating rather than nausea/vomiting (online supplemental figure S6 from the …
Contributors MC wrote this Commentary.
Funding This study was funded by grants R01-DK122280 and R01-DK125680 from National Institutes of Health.
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.