Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)
Intervention: Transoral Incisionless Fundoplication (Procedure); Proton Pump Inhibitors; active control (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Blair A Jobe, MD, Principal Investigator, Affiliation: University of Pittsburgh
Nicole D Bouvy, MD, PhD, Principal Investigator, Affiliation: University Hospital Maastricht, The Netherlands
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).
Clinical Details
Official title: A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: GERD symptoms
Secondary outcome: PPI usageLower esophageal acid exposure Healed reflux esophagitis Rate of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
University Hospital Maastricht, Maastricht, Limburg 6229 HX, Netherlands; Recruiting
Nicole D Bouvy, MD, PhD, Phone: +31433876543, Ext: 6883, Email: n.bouvy@mumc.nl
Bart PL Witteman, MD, Phone: +31433876543, Email: bplwitteman@gmail.com
Nicole D Bouvy, MD, PhD, Principal Investigator
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15232, United States; Recruiting
Blair A Jobe, MD, Phone: 412-623-2025, Email: jobeba@upmc.edu
Bart PL Witteman, MD, Phone: 412-623-3073, Email: bplwitteman@gmail.com
Blair A Jobe, MD, Principal Investigator
Additional Information
Starting date: March 2009
Ending date: March 2011
Last updated: April 17, 2009
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