Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- % Acid Exposure Time (%AET)
研究概览
简要总结
This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.
详细描述
The study will examine whether a modified vertical sleeve gastrectomy (mVSG) will improve GERD and quality of life.
Aim 1 (Primary): to determine whether mVSG, in comparison to conventional vertical sleeve gastrectomy (cVSG), will be associated with lower acid exposure time (AET, measured by the Bravo pH test) at 6-9 months. The investigators hypothesize that, at Month 6-9, compared to cVSG:
• H1. mVSG will be associated with lower AET
Aim 2 (Secondary): To elucidate the mechanistic basis for Aim 1, the investigators will perform following tests, before and at 6-9 months post-surgery: a) High resolution esophageal manometry (HREM) to determine the lower esophageal sphincter (LES) and intragastric pressure; b) The endoluminal functional lumen imaging probe (EndoFLIP) testing to examine changes in compliance of the LES; c) Measure the length of the gastroesophageal flap valve (GEFV) on the retroflex view during endoscopic exam. The investigators hypothesize that, at Month 6-9, compared to cVSG:
- H2a. mVSG will be associated with higher LES pressure and lower intragastric pressure
- H2b. mVSG will be associated with lower LES compliance
- H2c. GEFV will be present after mVSG (vs absence after cVSG)
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
- Single (Participant)
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
- •Male and female subjects aged 18-65 years
- •Body mass index (BMI) 35-55 kg/m2
- •Must meet the BMI criteria before and after 6 months of nonsurgical weight management
- •Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
- •Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery
- •Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry and prior to surgery
- •Must be able to provide written informed consent
排除标准
- •Hiatal hernia >2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at the time of surgery)
- •Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
- •Severe gastroparesis
- •Previous bariatric or anti-reflux procedure
- •Barrett's esophagus
- •Subjects requiring mesh treatment at time of procedure
- •Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator
- •Subjects with pacemakers, implantable defibrillators, neurostimulators
- •Portal hypertension or cirrhosis
- •Chronic pancreatitis
- •Active cancer treatment
- •Inability to tolerate general anesthesia
- •Uncontrollable coagulopathy
- •Significant and uncontrolled inflammatory bowel disease
- •Severe and/or uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site.
- •Suicidal ideation or unstable/untreated major depressive disorder within the past year
- •Alcohol or substance use disorder within the past year.
- •Pregnant or breastfeeding or planning pregnancy in the coming 24 months
- •Diminished intellectual capacity to consent or follow pre- and post-surgery instructions
- •History of, or any current health condition that, in the opinion of the PI, would make the subject ineligible for sleeve gastrectomy, or put the subject at risk by participation in the study.
研究组 & 干预措施
Modified Vertical Sleeve Gastrectomy (mVSG)
modified investigational vertical sleeve gastrectomy (mVSG)
干预措施: Modified Vertical Sleeve Gastrectomy (mVSG) (Procedure)
Conventional Vertical Sleeve Gastrectomy (cVSG)
conventional vertical sleeve gastrectomy (cVSG)
干预措施: Conventional Vertical Sleeve Gastrectomy (cVSG) (Procedure)
结局指标
主要结局
% Acid Exposure Time (%AET)
时间窗: Pre-surgery, Month 6-9 post surgery
Change in %AET in percentage points at Month 6-9 relative to pre-surgery %AET assessed with the Bravo pH test
次要结局
- LES pressure(Pre-surgery, Month 6-9 post surgery)
- Intragastric pressure(Pre-surgery, Month 6-9 post surgery)
- LES compliance(Pre-surgery, Month 6-9 post surgery)
- GEFV length(Pre-surgery, Month 6-9 post surgery)
研究者
Nihn Tuan Nguyen
Professor
University of California, Irvine