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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235677
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : October 10, 2005
Information provided by:
UMC Utrecht

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Procedure: Endoscopic gastroplication Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Blinded, Randomized, Sham-Controlled Trial of Endoscopic Gastroplication for the Treatment of Gastroesophageal Reflux Disease
Study Start Date : August 2003
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Primary Outcome Measures :
  1. Antisecretory drugs use
  2. GERD symptoms (heartburn and regurgitation)

Secondary Outcome Measures :
  1. Quality of life
  2. 24-hr esophageal acid exposure
  3. Esophageal manometry
  4. Occurrence of adverse events

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

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

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 identifier (NCT number): NCT00235677

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Dept. of Gastroenterology, UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: Matthijs P Schwartz, PhD, MD UMC Utrecht
Study Director: Andre J Smout, PhD, MD UMC Utrecht

Layout table for additonal information Identifier: NCT00235677     History of Changes
Other Study ID Numbers: Endoplac
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: October 10, 2005
Last Verified: July 2005
Keywords provided by UMC Utrecht:
Endoscopic antireflux treatment
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases