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.
subjects must be 18-70 years of age
eligible for endoscopic and surgical weight loss procedures
body mass index (BMI) greater than 35 kg/m2
Individuals must be in excellent mental health
untreated H. pylori infection
gastroparesis
active smoking
an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
Adults in the Center for Weight Management and Wellness program at Brigham and Women's Hospital with a BMI \>35 kg/m2 who are pre-qualified by their insurance as recommended by their specialist to undergo an endoscopic bariatric procedure.
Cohort
Prospective
PSAM Treatment Patients
Procedure/SurgeryPSAM is a pylorus-sparing antral myotomy performed under general anesthesia. Endoscopic myotomy is then performed applying the principles of submucosal endoscopy and techniques used during gastric per-oral endoscopic myotomy (G-POEM). A submucosal bleb is created proximal to the pylorus. A longitudinal mucosal incision is made with an endoscopic knife. The endoscope is then introduced into the submucosal space, and the knife is used to dissect the submucosal fibers. Antral myotomy is performed starting proximal to the pyloric ring extending to the mucosal access site. The myotomy entails cutting of the inner circular and oblique muscle bundles or may be full thickness at the discretion of the endoscopist. The mucosal entry is then closed using endoscopic suturing or clips.
Weight change compared to baseline
Percent total body weight loss
Adverse Events
Changes to health compared to baseline
Change in tolerability from procedure day to 12 months
How the subjects feel after the procedure based on pain scale and AE's
Change in Quality of Life compared to baseline
Overall quality of life questionnaire
Gastric Emptying compared to baseline
Gastric emptying using a gastric emptying breath test (GEBT)
Ghrelin levels compared to baseline
Laboratory analysis of blood samples to test ghrelin levels
Insulin levels compared to baseline
Laboratory analysis of blood samples to test insulin metabolic profiles
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Christopher C. Thompson, MD, MSc
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
