Gastroesophageal Reflux Disease (GERD) | Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
Gastroesophageal Reflux Disease (GERD) research study
What is the primary objective of this 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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Gastroesophageal Reflux Disease (GERD)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Transoral Incisionless FundoplicationThe 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.
Drug:Proton Pump Inhibitors; active controlProton Pump Inhibitors; active control
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Proton Pump Inhibitors
Start Date: March 2009
Completed Date: December 2011
Phase: Phase 3
Primary Outcome: GERD symptoms
Secondary Outcome: PPI usage
Study sponsors, principal investigator, and references
Principal Investigator: Blair A Jobe, MD
Lead Sponsor: University of Pittsburgh
Collaborator: EndoGastric Solutions