Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percent TWL (%TWL)
研究概览
简要总结
The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.
详细描述
Obesity is a major global health concern. In the US, from 1999 through 2020, the prevalence of obesity has increased from 30.5% to 41.9%. Obesity, defined as the body mass index of more than 30 kg/m2, increases the risk of metabolic diseases and has become the leading cause of death including cardiovascular disease, stroke and cancers.
At present, obesity treatment ranges from lifestyle modification, pharmacotherapy, endoscopic to surgical intervention. Though bariatric surgery has proven to be the most effective treatment in terms of weight loss, it still carries the complication rates of 0.6% - 4.9%.
Endoscopic Bariatric and Metabolic Therapy (EBMT) has emerged as an alternative minimally invasive approach for the patients with morbid obesity with the body mass index (BMI) of 30 - 40 kg/m2. Endoscopic sleeve gastroplasty (ESG) involves placing sutures inside the stomach using an endoluminal full-thickness suturing device. This allows for gastric volume reduction and impaired gastric motility, which results in weight loss. Recent meta-analysis demonstrated ESG, using OverStitch suturing device, percent total weight loss (%TWL) of 16.09 - 16.43% at 12 months after procedure and a serious adverse event rate of 1 - 2.26%. With favorable outcomes and lower complication rates compared to bariatric surgery, ESG has been growing in popularity and increasingly performed worldwide. Other EBT cleared by the U.S. Food and Drug Administration for full thickness tissue approximation include the Incisionless Operating Platform endoscopic plication (USGI Medical, San Clemente, Calif, USA), and Endomina® (Endo Tools Therapeutic, Gosselies, Belgium) which creates gastric plications.
Currently, there is no standardization regarding suturing patterns. One suture pattern for gastric plication that has been used is the "belt and suspenders" pattern whereby plications sutures are placed in the distal gastric body along the width (belt) and mid/proximal gastric body (suspenders). This allows for gastric shortening and reduction in gastric volume. It is suspected this would also alter gastric motility. The distal gastric plications placed near the antrum would result in a disruption of gastric motility; decreased gastric motility would result in decrease gastric emptying and longer satiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 18-65 years of age
- •BMI ≥ 30 kg/m2
- •Capable of giving informed consent and available to return for follow-up visit
排除标准
- •Untreated H. pylori infection
- •Active gastric or duodenal ulceration
- •Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
- •Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
- •Esophageal or gastric varices and/or portal hypertensive gastropathy
- •Gastroparesis
- •History of gastric surgery/endoscopic procedure
- •Active psychological issues preventing participation in a lifestyle modification program
- •Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
- •Severe coagulopathy
- •Active smoking
- •Substance abuse
- •Serious health condition that increased risk of anesthesia and/or endoscopic procedure
- •Pregnancy or lactation
- •Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use
结局指标
主要结局
Percent TWL (%TWL)
时间窗: Baseline, 6 months, 12 months
Change in the percent total weight loss from baseline at 6 and 12 months.
Adverse Events
时间窗: 6 months, 12 months
Presence of adverse events that develop post-procedure
次要结局
- Gastric Emptying(Baseline, 6 month, 12 months)
- Obesity-related comorbidities - pre-diabetes/diabetes(Baseline, 6 months, 12 months)
- Obesity-related comorbidities - gastroesophageal reflux (GERD)(Baseline, 6 months, 12 months)
- Number of participants with improvement in fasting glucose(Baseline, 6 months, 12 months)
- Number of participants with improvement in Hemoglobin A1c (HgA1c %)(Baseline, 6 months, 12 months)
- Obesity-related comorbidities - change in hypertension concomitant medications(Baseline, 6 months, 12 months)
- Improvement in fasting lipids profile(Baseline, 6 months, 12 months)
- Number of participants with a change in ghrelin hormone values(Baseline, 6 months, 12 months)
- Obesity-related comorbidities - hypertension(Baseline, 6 months, 12 months)
- Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications(Baseline, 6 months, 12 months)
研究者
Christopher C. Thompson, MD, MSc
Director of Endoscopy
Brigham and Women's Hospital