Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment (TvP)
Primary Purpose
Gastroesophageal Reflux Disease (GERD)
Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Transoral Incisionless Fundoplication
Proton Pump Inhibitors; active control
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring GERD, endoscopic, fundoplication, Proton Pump Inhibitors, heartburn, anti-reflux surgery
Eligibility 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
Sites / Locations
- University Hospital Maastricht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EsophyX
Proton Pump Inhibitors
Arm Description
Outcomes
Primary Outcome Measures
GERD symptoms
GERD symptoms
GERD symptoms
Secondary Outcome Measures
PPI usage
Lower esophageal acid exposure
Esophagitis
Percentage of Participants with Esophagitis (Los Angeles classification scale)
Rate of adverse events
Full Information
NCT ID
NCT00857597
First Posted
March 4, 2009
Last Updated
March 28, 2018
Sponsor
University of Pittsburgh
Collaborators
EndoGastric Solutions, Sandhill Scientific, Crospon
1. Study Identification
Unique Protocol Identification Number
NCT00857597
Brief Title
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
Acronym
TvP
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated after unplanned interim analysis of single centre data and results were reported
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
EndoGastric Solutions, Sandhill Scientific, Crospon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
GERD, endoscopic, fundoplication, Proton Pump Inhibitors, heartburn, anti-reflux surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EsophyX
Arm Type
Experimental
Arm Title
Proton Pump Inhibitors
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Transoral Incisionless Fundoplication
Other Intervention Name(s)
TIF procedure, ELF procedure, Endoluminal fundoplication, Endoscopic fundoplication
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Proton Pump Inhibitors; active control
Other Intervention Name(s)
Esomeprazole, Lansomeprazole, Omeprazole, Pantoprazole, Rabeprazole, Nexium, Prevacid, Dakar, Lanso, Lanzor, Prezal, Lanzol, Prilosec, Losec, Logastric, Protonix, Zurcal, Pantozol, Zurcale, Aciphex, Pariet
Intervention Description
Proton Pump Inhibitors; active control
Primary Outcome Measure Information:
Title
GERD symptoms
Time Frame
Baseline
Title
GERD symptoms
Time Frame
6 month follow-up
Title
GERD symptoms
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
PPI usage
Time Frame
at 0, 6 and 12 month follow- up
Title
Lower esophageal acid exposure
Time Frame
at 0, 6 and 12 month follow- up
Title
Esophagitis
Description
Percentage of Participants with Esophagitis (Los Angeles classification scale)
Time Frame
at 0, 6 and 12 month follow- up
Title
Rate of adverse events
Time Frame
at 0, 6 and 12 month follow- up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blair A Jobe, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole D Bouvy, MD, PhD
Organizational Affiliation
University Hospital Maastricht, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/25823768
Description
Data reported in Am J Gastroenterol. 2015 Apr;110(4):531-42. doi: 10.1038/ajg.2015.28. Epub 2015 Mar 31.
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Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
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