Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

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

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• ASA > 2
• 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