Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Body weight
时间窗: baseline, 1,3,6,12 months
Weight change compared to baseline
Adverse events
时间窗: within 30 days of procedure
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
次要结局
- Technical success rate(1 day)
- Serum ghrelin levels(baseline, 1,3,6,12 months)
- Blood pressure(baseline, 1,3,6,12 months)
- Lipid profile(baseline, 1,3,6,12 months)
- Gastric emptying symptoms(baseline, 1,6,12 months)
- Fasting glucose level(baseline, 1,3,6,12 months)
- Pain scale after procedure(3 days)
- Change in Quality of Life(baseline, 1,6,12 months)
- Insulin level(baseline, 1,3,6,12 months)
- HbA1c level(baseline, 1,3,6,12 months)
- serum liver parameters(baseline, 1,3,6,12 months)
- hepatic steatosis index(baseline, 1,3,6,12 months)
- NAFLD fibrosis(baseline, 1,3,6,12 months)
- obstructive sleep apnea(baseline, 1,3,6,12 months)
研究者
Stephen KK Ng
Principal Investigator
Chinese University of Hong Kong