Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure

Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The Pylorus Sparing Antral Myotomy (PSAM) technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body. PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability (GCSI score) or the safety profile of the procedure (2 DDW GEM abstracts). PSAM has not been evaluated alone, without concomitant ESG. Since delayed gastric emptying alone is known to promote weight loss, it is thought that PSAM alone (without ESG) may provide similar efficacy, while reducing procedure time and adverse events. There have been no clinical studies that investigate the efficacy of PSAM independent of ESG. This pilot study aims to address this lack of information by evaluating the safety, tolerability, and short-term efficacy of PSAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial.

Inclusion Criteria:subjects must be 18-70 years of ageeligible for endoscopic and surgical weight loss proceduresbody mass index (BMI) greater than 35 kg/m2Individuals must be in excellent mental healthable to understand and sign informed consentavailable to return for all routine follow-up study visitsExclusion Criteria:untreated H. pylori infectiongastroparesisactive smokingan ongoing or a history of treatment with opioids in the last 12 months prior to enrollmentprevious pyloromyotomy or pyloroplastygastrointestinal obstructionsevere coagulopathyesophageal or gastric varices and/or portal hypertensive gastropathypregnancy or puerperiumany inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)lactationhistory of gastrointestinal surgeryany serious health condition unrelated to their weight that would increase the risk of endoscopychronic abdominal painactive psychological issues preventing participation in a lifestyle modification programa known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)an inability to provide informed consentuse of any medication that may interfere with weight lossuse of any medication that may interfere with gastric emptyingany other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study