Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

Not Applicable

Completed

• Conditions: Hiatal Hernia; Gastroesophageal Reflux Disease
• Interventions: Procedure: Transoral Incisionless Fundoplication (TIF)

• Registration Number: NCT01110811
• Lead Sponsor: EndoGastric Solutions

Brief Summary

The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.

Detailed Description

Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).

Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2015-09
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

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

Inclusion Criteria

• Age 18-80 years
• On daily PPIs for > 6 months
• Documented PPI dependency
• Persistent GERD symptoms without PPI therapy during the titration phase of the study
• Evidence of two or more of the following while off PPI therapy (> 10 days):
• Erosive esophagitis (Los Angeles grade A-C)
• Abnormal ambulatory pH study
• Moderate to severe GERD symptoms
• Normal or near normal esophageal motility (by manometry)
• Patient willing to cooperate with post-operative dietary recommendations and assessment tests
• Signed informed consent

Exclusion Criteria

• BMI > 35
• Hiatal hernia > 3 cm
• Esophagitis LA grade D
• Esophageal ulcer
• Esophageal stricture
• Barretts esophagus (Prague: C>1, M>2)
• Esophageal motility disorder
• Severe gastric paralysis
• Pregnancy or plans for pregnancy in the next 12 months
• Immunosuppression
• ASA > 2
• Portal hypertension and/or varices
• History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
• Active gastro-duodenal ulcer disease
• Gastric outlet obstruction or stenosis
• Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
• Coagulation disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham procedure	Transoral Incisionless Fundoplication (TIF)	The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy).
TIF procedure	Transoral Incisionless Fundoplication (TIF)	Transoral Incisionless Fundoplication (TIF)

Primary Outcome Measures

Name	Time	Method
Proportion of patients in clinical remission	at 6 month follow-up	Fifty nine per cent of patients remained in clinical remission

Secondary Outcome Measures

Name	Time	Method
Reduction in symptoms	at 6 moths follow-up	GSRS score improved from 14 (range 10-21) to 10 (range 6-19) with P = 0.004.
Normalized esophageal acid exposure	at 6 months follow-up	Sixty nine per cent of patients (69%) in TIF surgical arm normalized esophageal acid exposure.
Healed reflux esophagitis	at 6 months follow-up	In 80% of patients healing of esophagitis was observed

Trial Locations

Locations (4)

University of Nantes Hospital; 🇫🇷 Nantes, France

Karolinska University, Ersta Hospital; 🇸🇪 Stockholm, Sweden

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Karolinska University, Huddinge Hospital; 🇸🇪 Stockholm, Sweden