Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment

Phase 3

Terminated

• Conditions: Gastroesophageal Reflux Disease (GERD)
• Interventions: Procedure: Transoral Incisionless Fundoplication; Drug: Proton Pump Inhibitors; active control

• Registration Number: NCT00857597
• Lead Sponsor: University of Pittsburgh

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2016-10
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EsophyX	Transoral Incisionless Fundoplication	-
Proton Pump Inhibitors	Proton Pump Inhibitors; active control	-

Primary Outcome Measures

Name	Time	Method
GERD symptoms	12 month follow-up

Secondary Outcome Measures

Name	Time	Method
PPI usage	at 0, 6 and 12 month follow- up
Lower esophageal acid exposure	at 0, 6 and 12 month follow- up
Esophagitis	at 0, 6 and 12 month follow- up	Percentage of Participants with Esophagitis (Los Angeles classification scale)
Rate of adverse events	at 0, 6 and 12 month follow- up

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands