Treatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication, A Placebo-Controlled Study

October 6, 2005 updated by: UMC Utrecht

A Blinded, Randomized, Sham-Controlled Trial of Endoscopic Gastroplication for the Treatment of Gastroesophageal Reflux Disease

Aim:

To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure.

The hypotheses tested in this study were that active treatment would: 1) decrease the use of antisecretory medication, 2) decrease GERD symptoms, 3) improve quality of life, and 4) reduce esophageal acid exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastroesophageal reflux disease (GERD) and the chronic, often lifelong, use of antisecretory medication have great clinical and economical implications for the patient, practicing physician and society in general. The currently available medication in GERD is very effective against heartburn, but less against the symptom of regurgitation. Surgical antireflux treatment offers a good alternative. The current surgical approach, a laparoscopic fundoplication, is safe and effective (a 90% reduction in use of antireflux medication), but in a significant subgroup of patients new symptoms arise (dysphagia, bloating) and perioperative morbidity, as well as financial costs are relatively high.

An endoscopic suturing system has been developed, offering a minimally invasive antireflux treatment, which can be performed in an outpatient setting. The procedure aims to create an endoscopic fundoplication, and could possibly serve as an alternative to antireflux medication and surgery. Recent, uncontrolled studies, have shown that the results of the endoscopic suturing system are satisfactory and that the procedure is safe.

This single-center, double-blinded, randomized, sham-controlled trial was conducted to evaluate the efficacy of endoscopic gastroplication by the Endocinch suturing system. Sixty patients with daily symptoms of GERD and abnormal esophageal 24-hr pH monitoring were randomly assigned to three endoscopic gastroplications (n = 20), to a sham procedure (n = 20) or to observation (n = 20). Primary endpoints were proton pump inhibitor use and GERD symptoms. Secondary endpoints were quality of life, 24-hr esophageal acid exposure, esophageal manometry and the occurrence of adverse events. Follow-up assessments were performed at 3 months. The research nurse and patients in the active and sham groups were blinded to the procedure assignment.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 3

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

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Dept. of Gastroenterology, UMC Utrecht

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:

  • typical symptoms of GERD (i.e., heartburn, regurgitation) for > 6 months,
  • pathological esophageal acid exposure after discontinuation of medical therapy, proven by ambulatory 24-hour pH-monitoring with > 5% of time a pH < 4 and a symptom-association probability > 95% (19)
  • patients considered for non-medical therapy, i.e. unwillingness to take life-long medication in medically-responding disease, suffering from medication side-effects or medically-intractable disease and unwillingness to undergo surgery
  • willingness to accept a pre-treatment observation period of three months duration
  • written informed consent

Exclusion Criteria:

  • severe preexisting esophageal motility disorder (i.e., more than >40% non-transmitted or simultaneous contractions during a short esophageal manometry study)
  • hiatal hernia (> 3 cm in length)
  • history of antireflux or esophageal/gastric surgery
  • severe psychiatric disease
  • reflux esophagitis grade D (LA classification)
  • Barrett's esophagus with dysplasia
  • esophageal stenosis/malignancy
  • pregnancy or lactation
  • history of low therapeutic compliance
  • other severe comorbidity (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorder)
  • use of anticoagulant or immunosuppressive drugs
  • history of alcohol or drug abuse

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: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Antisecretory drugs use
GERD symptoms (heartburn and regurgitation)

Secondary Outcome Measures

Outcome Measure
Quality of life
Occurrence of adverse events
24-hr esophageal acid exposure
Esophageal manometry

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Matthijs P Schwartz, PhD, MD, UMC Utrecht
  • Study Director: Andre J Smout, PhD, MD, UMC Utrecht

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

August 1, 2003

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (ESTIMATE)

October 10, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2005

Last Update Submitted That Met QC Criteria

October 6, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endoplac

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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