Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: Crospon; EndoGastric Solutions; Sandhill Scientific
• Treatments: Esomeprazole; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Rabeprazole

Criteria

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