Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment - Full Text View

Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment (TvP)

This study is currently recruiting participants.

Verified by University of Pittsburgh, April 2009

First Received: March 4, 2009 Last Updated: April 17, 2009 History of Changes

Sponsor:	University of Pittsburgh
Collaborators:	EndoGastric Solutions Sandhill Scientific Inc. Crospon
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00857597

Purpose

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).

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Procedure: Transoral Incisionless Fundoplication Drug: Proton Pump Inhibitors; active control	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy GERD

Drug Information available for: Omeprazole Omeprazole magnesium Pantoprazole Lansoprazole E 3810 Pantoprazole Sodium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

GERD symptoms [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PPI usage [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Lower esophageal acid exposure [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Healed reflux esophagitis [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: No ]
Rate of adverse events [ Time Frame: at 0, 6 and 12 month follow- up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EsophyX: Experimental	Procedure: Transoral Incisionless Fundoplication 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 Comparator	Drug: Proton Pump Inhibitors; active control Proton Pump Inhibitors; active control

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857597

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Blair A Jobe, MD 412-623-2025 jobeba@upmc.edu
Contact: Bart PL Witteman, MD 412-623-3073 bplwitteman@gmail.com
Principal Investigator: Blair A Jobe, MD
Netherlands, Limburg
University Hospital Maastricht	Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Nicole D Bouvy, MD, PhD +31433876543 ext 6883 n.bouvy@mumc.nl
Contact: Bart PL Witteman, MD +31433876543 bplwitteman@gmail.com
Principal Investigator: Nicole D Bouvy, MD, PhD

Sponsors and Collaborators

University of Pittsburgh

EndoGastric Solutions

Sandhill Scientific Inc.

Crospon

Investigators

Principal Investigator:	Blair A Jobe, MD	University of Pittsburgh
Principal Investigator:	Nicole D Bouvy, MD, PhD	University Hospital Maastricht, The Netherlands

More Information

No publications provided

Responsible Party:	University of Pittsburgh Medical Center ( Blair A Jobe, MD )
Study ID Numbers:	D00668-01C
Study First Received:	March 4, 2009
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00857597 History of Changes
Health Authority:	United States: Institutional Review Board; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University of Pittsburgh:

GERD
endoscopic
fundoplication

Proton Pump Inhibitors
heartburn
anti-reflux surgery

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

Gastrointestinal Diseases
Enzyme Inhibitors
Esophageal Diseases
Gastroesophageal Reflux
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010