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

Primary Purpose

Gastroesophageal Reflux Disease, Hiatal Hernia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transoral Incisionless Fundoplication (TIF)
Sponsored by
EndoGastric Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven
  • University of Nantes Hospital
  • Karolinska University, Ersta Hospital
  • Karolinska University, Huddinge Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TIF procedure

Sham procedure

Arm Description

Transoral Incisionless Fundoplication (TIF)

The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy).

Outcomes

Primary Outcome Measures

Proportion of patients in clinical remission
Fifty nine per cent of patients remained in clinical remission

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2010
Last Updated
March 4, 2019
Sponsor
EndoGastric Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01110811
Brief Title
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoGastric Solutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Hiatal Hernia
Keywords
GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIF procedure
Arm Type
Active Comparator
Arm Description
Transoral Incisionless Fundoplication (TIF)
Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy).
Intervention Type
Procedure
Intervention Name(s)
Transoral Incisionless Fundoplication (TIF)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients in clinical remission
Description
Fifty nine per cent of patients remained in clinical remission
Time Frame
at 6 month follow-up
Secondary Outcome Measure Information:
Title
Reduction in symptoms
Description
GSRS score improved from 14 (range 10-21) to 10 (range 6-19) with P = 0.004.
Time Frame
at 6 moths follow-up
Title
Normalized esophageal acid exposure
Description
Sixty nine per cent of patients (69%) in TIF surgical arm normalized esophageal acid exposure.
Time Frame
at 6 months follow-up
Title
Healed reflux esophagitis
Description
In 80% of patients healing of esophagitis was observed
Time Frame
at 6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Lundell, M.D.
Organizational Affiliation
Karolinska University, Huddinge Hospital, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Facility Name
University of Nantes Hospital
City
Nantes
Country
France
Facility Name
Karolinska University, Ersta Hospital
City
Stockholm
Country
Sweden
Facility Name
Karolinska University, Huddinge Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26463242
Citation
Hakansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015 Dec;42(11-12):1261-70. doi: 10.1111/apt.13427. Epub 2015 Oct 13.
Results Reference
derived

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

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