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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gastroesophageal Reflux Disease, Hiatal Hernia

Intervention / Treatment
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* Procedure: Transoral Incisionless Fundoplication (TIF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TIF procedure<br>Transoral Incisionless Fundoplication (TIF) | Procedure: Transoral Incisionless Fundoplication (TIF)<br>* The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.<br>|
| Sham Comparator: Sham procedure<br>The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy). | Procedure: Transoral Incisionless Fundoplication (TIF)<br>* The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in clinical remission | Fifty nine per cent of patients remained in clinical remission | at 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in symptoms | GSRS score improved from 14 (range 10-21) to 10 (range 6-19) with P = 0.004. | at 6 moths follow-up | 
| Normalized esophageal acid exposure | Sixty nine per cent of patients (69%) in TIF surgical arm normalized esophageal acid exposure. | at 6 months follow-up | 
| Healed reflux esophagitis | In 80% of patients healing of esophagitis was observed | at 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent