Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
Lead SponsorUniversity of Pittsburgh
Indication/ConditionGastroesophageal Reflux Disease (GERD)
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).
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.
Proton Pump Inhibitors; active control
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