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

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).

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