RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure: A Pilot Study

Quick Facts

Study Start:2023-09-22
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05711758

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * subjects must be 18-70 years of age
  2. * eligible for endoscopic and surgical weight loss procedures
  3. * body mass index (BMI) greater than 35 kg/m2
  4. * Individuals must be in excellent mental health
  5. * able to understand and sign informed consent
  6. * available to return for all routine follow-up study visits
  1. * untreated H. pylori infection
  2. * gastroparesis
  3. * active smoking
  4. * an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
  5. * previous pyloromyotomy or pyloroplasty
  6. * gastrointestinal obstruction
  7. * severe coagulopathy
  8. * esophageal or gastric varices and/or portal hypertensive gastropathy
  9. * pregnancy or puerperium
  10. * 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)
  11. * malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)
  12. * 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)
  13. * lactation
  14. * history of gastrointestinal surgery
  15. * any serious health condition unrelated to their weight that would increase the risk of endoscopy
  16. * chronic abdominal pain
  17. * active psychological issues preventing participation in a lifestyle modification program
  18. * a known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
  19. * an inability to provide informed consent
  20. * use of any medication that may interfere with weight loss
  21. * use of any medication that may interfere with gastric emptying
  22. * any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study

Contacts and Locations

Study Contact

Michele B. Ryan, MS
CONTACT
6176765928
mryan@bwh.harvard.edu

Principal Investigator

Christopher C. Thompson, MD, MSc
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Christopher C. Thompson, MD, MSc

  • Christopher C. Thompson, MD, MSc, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Pylorus Sparing Antral Myotomy (PSAM)
  • Gastric physiology
  • Gastric emptying
  • Pylorus-sparing antral myotomy
  • Myotomy
  • Endoscopic Sleeve Gastroplasty (ESG)
  • TransPyloric Shuttle (TPS)
  • Intragastric balloon (IGB)
  • Endoscopic bariatric and metabolic therapies (EBMT)
  • Gut Hormones
  • Gastric Emptying Breath Test

Additional Relevant MeSH Terms

  • Obesity
  • Obesity, Morbid
  • Obesity, Primary
  • Metabolic Disease
  • Delayed Gastric Emptying Following Procedure