Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity

In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin). This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.

Sex

All

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

1. Subjects must be 18-70 years of age
2. Are currently in the CWMW lifestyle modification program
3. Have a diagnostic endoscopy approved for bariatric evaluation
4. Eligible for endoscopic and surgical weight loss procedures
5. Body mass index (BMI) 30-50 kg/m2
6. Individuals must be in excellent mental health
7. Able to understand and sign informed consent
8. Available to return for all routine follow-up study visits

Exclusion Criteria:

1. Untreated H. pylori infection
2. Active smoking
3. Ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
4. Previous pyloromyotomy or pyloroplasty
5. Gastrointestinal obstruction
6. Severe coagulopathy
7. Esophageal or gastric varices and/or portal hypertensive gastropathy
8. Pregnancy or puerperium
9. Any 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)
10. Malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)
11. 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)
12. Lactation
13. History of gastrointestinal surgery
14. Any serious health condition unrelated to their weight that would increase the risk of endoscopy
15. Chronic abdominal pain
16. Active psychological issues preventing participation in a lifestyle modification program
17. A known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
18. An inability to provide informed consent
19. Use of any medication that may interfere with weight loss
20. Use of any medication that may interfere with gastric emptying
21. Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.

• BACKGROUNDKlem ML, Wing RR, Chang CC, Lang W, McGuire MT, Sugerman HJ, Hutchison SL, Makovich AL, Hill JO. A case-control study of successful maintenance of a substantial weight loss: individuals who lost weight through surgery versus those who lost weight through non-surgical means. Int J Obes Relat Metab Disord. 2000 May;24(5):573-9. doi: 10.1038/sj.ijo.0801199. PMID 10849578
• BACKGROUNDJames PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001 Nov;9 Suppl 4:228S-233S. doi: 10.1038/oby.2001.123. PMID 11707546
• BACKGROUNDJia H, Lubetkin EI. Obesity-related quality-adjusted life years lost in the U.S. from 1993 to 2008. Am J Prev Med. 2010 Sep;39(3):220-7. doi: 10.1016/j.amepre.2010.03.026. PMID 20709253
• BACKGROUNDMcCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614. PMID 31592891
• BACKGROUNDAbu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24. PMID 23711556
• BACKGROUNDGomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28. PMID 27465076
• BACKGROUNDHedjoudje A, Abu Dayyeh BK, Cheskin LJ, Adam A, Neto MG, Badurdeen D, Morales JG, Sartoretto A, Nava GL, Vargas E, Sui Z, Fayad L, Farha J, Khashab MA, Kalloo AN, Alqahtani AR, Thompson CC, Kumbhari V. Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 May;18(5):1043-1053.e4. doi: 10.1016/j.cgh.2019.08.022. Epub 2019 Aug 20.