Endoscopic Sleeve Gastroplasty with Fundal Mucosal Ablation - 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
Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure.
Recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. Combining endoscopic gastric fundus mucosal ablation with ESG could potentially enhance the weight loss effects of ESG while maintaining an acceptable safety profile.
This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA) in obese patients 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)
- •Previous ESG
- •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
研究组 & 干预措施
Endoscopic sleeve gastroplasty with fundal mucosal ablation
First part of procedure - endoscopic gastric fundus mucosal ablation Second part of procedure - endoscopic sleeve gastroplasty
干预措施: Endoscopic sleeve gastroplasty with fundal mucosal ablation (Procedure)
结局指标
主要结局
Body weight
时间窗: baseline, 1,3,6,12 months
Weight change compared to baseline
次要结局
- Blood pressure(baseline, 1,3,6,12 months)
- Lipid profile(baseline, 3,6,12 months)
- NAFLD fibrosis(baseline, 3,6,12 months)
- HbA1c level(baseline, 3,6,12 months)
- hepatic steatosis index(baseline, 3,6,12 months)
- Adverse events(within 30 days of procedure)
- Technical success rate(1 day)
- Serum ghrelin levels(baseline, 3,6,12 months)
- Pain scale after procedure(3 days)
- Change in Quality of Life(baseline, 3,6,12 months)
- Gastric emptying symptoms(baseline, 3,6,12 months)
- Eating behaviors(baseline, 3,6,12 months)
- Fasting glucose level(baseline, 3,6,12 months)
- Insulin level(baseline, 3,6,12 months)
研究者
Stephen KK Ng
Principal Investigator
Chinese University of Hong Kong