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

March 4, 2019 updated by: EndoGastric Solutions

A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • University Hospitals Leuven
  • France
      • Nantes, France
        • University of Nantes Hospital
  • Sweden
      • Stockholm, Sweden
        • Karolinska University, Ersta Hospital
      • Stockholm, Sweden
        • Karolinska University, Huddinge Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TIF procedure
Transoral Incisionless Fundoplication (TIF)
Procedure: Transoral Incisionless Fundoplication (TIF)
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.
Sham Comparator: Sham procedure
The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy).
Procedure: Transoral Incisionless Fundoplication (TIF)
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients in clinical remission
Time Frame: at 6 month follow-up
Fifty nine per cent of patients remained in clinical remission
at 6 month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EndoGastric Solutions

Investigators

  • Principal Investigator: Lars Lundell, M.D., Karolinska University, Huddinge Hospital, Stockholm, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2009-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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