Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Total body weight loss [Срок оценки: 6 months]
• BMI change from baseline [Срок оценки: 6 months]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

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

Идентификаторы

NCT: NCT07612527 · BEAM-GFMA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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