BEAM for Weight Loss - a Pilot Study

Официальное название

Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study

Обзор

Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies.

Вмешательства

• Процедура Bariatric endoscopic antral myotomy
  A mucosal incision is performed using a triangle-tip knife J at the level of the incisura along the level of the greater curvature. Submucosal tunneling is then performed and stopped immediately proximal to the pylorus. Two parallel lines of partial thickness myotomy are then performed from the distal to proximal antrum using the same endoscopic knife. The myotomy is stopped approximately 2 cm distal to the mucosal incision site. Finally, the mucosal incision is closed using endoclips after haem

Первичные конечные точки

• Body weight [Срок оценки: baseline, 1,3,6,12 months]
• Adverse events [Срок оценки: within 30 days of procedure]

Вторичные конечные точки (12)

• Technical success rate [Срок оценки: 1 day]
• Serum ghrelin levels [Срок оценки: baseline, 1,3,6,12 months]
• Blood pressure [Срок оценки: baseline, 1,3,6,12 months]
• Lipid profile [Срок оценки: baseline, 1,3,6,12 months]
• Pain scale after procedure [Срок оценки: 3 days]
• Change in Quality of Life [Срок оценки: baseline, 1,6,12 months]
• Gastric emptying symptoms [Срок оценки: baseline, 1,6,12 months]
• Fasting glucose level [Срок оценки: baseline, 1,3,6,12 months]
• Insulin level [Срок оценки: baseline, 1,3,6,12 months]
• HbA1c level [Срок оценки: baseline, 1,3,6,12 months]
• serum liver parameters [Срок оценки: baseline, 1,3,6,12 months]
• hepatic steatosis index [Срок оценки: baseline, 1,3,6,12 months]

Критерии участия

Критерии включения

• BMI equal or more than 30kg/m2 (27.5kg/m2 for Chinese or South Asian) to 40kg/m2, or BMI equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, AND
• failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination

Критерии исключения

• Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
• Gastroparesis
• Active smoking
• An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
• Previous pyloromyotomy or pyloroplasty
• Gastrointestinal obstruction
• Use of any medication that may interfere with weight loss or gastric emptying
• Severe coagulopathy
• Esophageal or gastric varices and/or portal hypertensive gastropathy
• Underlying uncontrolled endocrine problem that leads to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc.)
• 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)
• Malignancy
• Pregnant or breast feeding
• Patients not fit for general anesthesia
• ASA grade IV or V
• Mental or psychiatric disorder; Drug or alcohol addiction
• Other cases deemed by the examining physician as unsuitable for safe treatment
• Refusal to participate

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

Гонконг · 1 центр

• Chinese University of Hong Kong — Shatin

Идентификаторы

NCT: NCT06622382 · CRE-2024.223

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗