Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

Official title

Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation for The Management of Obesity

Overview

The gastric fundus regulates appetite through orexigenic ghrelin-mediated and anorexigenic visceroceptive pathways. Accordingly, endoscopic gastric fundal mucosal ablation (GFMA) may benefit patients with obesity. Ablation not only affects these mechanisms, but similar to what happens after mucosal ablation for other indications (e.g. ESD for tumor removal), it is expected to cause shrinking of the fundus and reduce gastric volume. Another potential target to achieve weight loss is gastric emptying. This is a critical step in digestion that has been found to be more rapid after prolonged exposure to a high-fat diet in both animal and human studies, with rapid emptying also being more common in young people with obesity in some studies. The bariatric endoscopic antral myotomy (BEAM) procedure has been shown to consistently delay gastric emptying without triggering symptoms of gastroparesis and to produce substantial weight loss. Both GFMA and BEAM procedures have the advantages of being minimally invasive, performed completely endoscopic and less costly than surgical alternatives or other known endoscopic techniques like intragastric balloon or endoscopic sleeve gastroplasty.

Interventions

• Procedure Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)
  All patients in intervention arm will undergo the following steps: A. GFMA: Injection of saline/methylene blue solution in the gastric fundal submucosa including the fundal dome and upper half of the greater curvature, sparing 1cm just below the cardia and the whole lesser curvature opposite this area. Argon plasma coagulation will then be applied to ablate the mucosa of this area using ERBE VIO3 generator with settings of Pulsed APC, Effect 2, flow rate 1 L/minutes, 50-60W to achieve a golden

Primary outcome measures

• Total body weight loss [Time frame: 6 months]
• BMI change from baseline [Time frame: 6 months]

Secondary outcome measures (3)

• Gastric emptying time change from baseline [Time frame: 6 months]
• Gastric volume change from baseline [Time frame: 6 months]
• Fasting serum ghrelin change from baseline [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

Body mass index (BMI) of ≥ 30 kg/m2 up to 40 kg/m2. BMI of 27.0 to 29.9 kg/m2 will be included on the condition of the presence of at least 1 obesity-related comorbidity (Indications based according to the American and European societies for bariatric endoscopy guidelines)

Exclusion criteria

• Subjects with any previous surgeries to the stomach
• Any previous bariatric procedures
• Any current medications for the management of obesity (must be stopped at least 3 months before recruitment)
• Evidence of severe gastritis, gastric peptic ulcer, or gastric cancer
• Coagulopathy
• Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Kar-Alaini hospital (Cairo Univeristy hospital) — Cairo

Identifiers

NCT: NCT07612527 · BEAM-GFMA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗