Bariatric Endoscopy, Obesity & Overweight
Conditions
Brief summary
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
PROCEDUREGastric 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 yellow discoloration of the mucosa B. BEAM will then be performed during the same exam as follows: 1. Submucosal injection by saline in the distal greater curvature about 8 cm proximal to the pylorus. 2. Using an ESD knife, a mucosal incision will be performed horizontally in the injected bleb 3. Submucosal tunneling down to the pyloric muscle 4. Partial thickness antral myotomy along the tunnel 1cm proximal to the pyloric muscle 5. Mucosal incision site will be sealed by endoscopic clips
Sponsors
Cairo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total body weight loss | 6 months |
| BMI change from baseline | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Gastric emptying time change from baseline | 6 months |
| Gastric volume change from baseline | 6 months |
| Fasting serum ghrelin change from baseline | 6 months |
Countries
Egypt
Contacts
CONTACTHany Shehab, MD, FRCP
CONTACTFatma Elrashdy
Outcome results
None listed