NCT01110811

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

5.4 years

First QC Date

April 23, 2010

Last Update Submit

March 4, 2019

Conditions

Gastroesophageal Reflux DiseaseHiatal Hernia

Keywords

GERDEsophagitisFundoplicationAnti-reflux surgeryPPI dependent

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in clinical remission

    Fifty nine per cent of patients remained in clinical remission

    at 6 month follow-up

Secondary Outcomes (3)

  • Reduction in symptoms

    at 6 moths follow-up

  • Normalized esophageal acid exposure

    at 6 months follow-up

  • Healed reflux esophagitis

    at 6 months follow-up

Study Arms (2)

TIF procedure

ACTIVE COMPARATOR

Transoral Incisionless Fundoplication (TIF)

Procedure: Transoral Incisionless Fundoplication (TIF)

Sham procedure

SHAM COMPARATOR

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

Procedure: Transoral Incisionless Fundoplication (TIF)

Interventions

Transoral Incisionless Fundoplication (TIF)PROCEDURE

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 procedureTIF procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospitals Leuven

Leuven, Belgium

Location

University of Nantes Hospital

Nantes, France

Location

Karolinska University, Ersta Hospital

Stockholm, Sweden

Location

Karolinska University, Huddinge Hospital

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 26463242DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxHernia, HiatalEsophagitis

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGastroenteritis

Study Officials

  • Lars Lundell, M.D.

    Karolinska University, Huddinge Hospital, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 27, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2015

Study Completion

December 1, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

SE(2)BE(1)FR(1)