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

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ClinicalTrials.gov Identifier: NCT01110811
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Hiatal Hernia Procedure: Transoral Incisionless Fundoplication (TIF) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2010
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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.




Primary Outcome Measures :
  1. Proportion of patients in clinical remission [ Time Frame: at 6 month follow-up ]
    Fifty nine per cent of patients remained in clinical remission


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Healed reflux esophagitis [ Time Frame: at 6 months follow-up ]
    In 80% of patients healing of esophagitis was observed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110811


Locations
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Belgium
University Hospitals Leuven
Leuven, Belgium
France
University of Nantes Hospital
Nantes, France
Sweden
Karolinska University, Ersta Hospital
Stockholm, Sweden
Karolinska University, Huddinge Hospital
Stockholm, Sweden
Sponsors and Collaborators
EndoGastric Solutions
Investigators
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Principal Investigator: Lars Lundell, M.D. Karolinska University, Huddinge Hospital, Stockholm, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: EndoGastric Solutions
ClinicalTrials.gov Identifier: NCT01110811     History of Changes
Other Study ID Numbers: D2009-10
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Keywords provided by EndoGastric Solutions:
GERD
Esophagitis
Fundoplication
Anti-reflux surgery
PPI dependent
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Hernia, Hiatal
Hernia
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Hernia, Diaphragmatic