Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

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 GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).

Official Title
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A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Procedure: Transoral Incisionless Fundoplication
* Drug: Proton Pump Inhibitors; active control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years Proven gastroesophageal reflux (pH < 4 for > 4.3% time while off PPIs for 7-14 days) On daily PPIs for > 1 year Recurrence of GERD symptoms (GERD-HRQL score difference of > 10 between on and off PPIs) Normal or hypotonic LES resting pressure (5-40 mmHg) Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol Signed informed consent Exclusion Criteria: BMI > 35 Hiatal hernia > 2 cm Esophagitis grade D Barrett's esophagus Esophageal stricture Esophageal ulcer Esophageal motility disorder Gastric motility disorder Prior splenectomy Gastric paralysis Pregnancy (in females) Immunosuppression ASA > 2 Portal hypertension Coagulation disorders Previous antireflux procedure Any other health condition, which the investigator believes would prevent the patient from completing the study Lack of fluency in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EsophyX<br> | Procedure: Transoral Incisionless Fundoplication<br>* The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference.<br>* Other names: Endoscopic fundoplication;|
| Active Comparator: Proton Pump Inhibitors<br> | Drug: Proton Pump Inhibitors; active control<br>* Proton Pump Inhibitors; active control<br>* Other names: Pariet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD symptoms |  | Baseline | 
| GERD symptoms |  | 6 month follow-up | 
| GERD symptoms |  | 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPI usage |  | at 0, 6 and 12 month follow- up | 
| Lower esophageal acid exposure |  | at 0, 6 and 12 month follow- up | 
| Esophagitis | Percentage of Participants with Esophagitis (Los Angeles classification scale) | at 0, 6 and 12 month follow- up | 
| Rate of adverse events |  | at 0, 6 and 12 month follow- up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, endoscopic, fundoplication, Proton Pump Inhibitors, heartburn, anti-reflux surgery