A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Proportion of patients in clinical remission
研究概览
简要总结
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.
详细描述
Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).
Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •On daily PPIs for > 6 months
- •Documented PPI dependency
- •Persistent GERD symptoms without PPI therapy during the titration phase of the study
- •Evidence of two or more of the following while off PPI therapy (> 10 days):
- •Erosive esophagitis (Los Angeles grade A-C)
- •Abnormal ambulatory pH study
- •Moderate to severe GERD symptoms
- •Normal or near normal esophageal motility (by manometry)
- •Patient willing to cooperate with post-operative dietary recommendations and assessment tests
- •Signed informed consent
排除标准
- •BMI > 35
- •Hiatal hernia > 3 cm
- •Esophagitis LA grade D
- •Esophageal ulcer
- •Esophageal stricture
- •Barretts esophagus (Prague: C>1, M>2)
- •Esophageal motility disorder
- •Severe gastric paralysis
- •Pregnancy or plans for pregnancy in the next 12 months
- •Immunosuppression
- •Portal hypertension and/or varices
- •History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
- •Active gastro-duodenal ulcer disease
- •Gastric outlet obstruction or stenosis
- •Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
- •Coagulation disorders
研究组 & 干预措施
TIF procedure
Transoral Incisionless Fundoplication (TIF)
干预措施: Transoral Incisionless Fundoplication (TIF) (Procedure)
Sham procedure
The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy).
干预措施: Transoral Incisionless Fundoplication (TIF) (Procedure)
结局指标
主要结局
Proportion of patients in clinical remission
时间窗: at 6 month follow-up
Fifty nine per cent of patients remained in clinical remission
次要结局
- Reduction in symptoms(at 6 moths follow-up)
- Normalized esophageal acid exposure(at 6 months follow-up)
- Healed reflux esophagitis(at 6 months follow-up)