Treatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication, A Placebo-Controlled Study
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Blinded, Randomized, Sham-Controlled Trial of Endoscopic Gastroplication for the Treatment of Gastroesophageal Reflux Disease|
- Antisecretory drugs use
- GERD symptoms (heartburn and regurgitation)
- Quality of life
- 24-hr esophageal acid exposure
- Esophageal manometry
- Occurrence of adverse events
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||August 2005|
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.
|Dept. of Gastroenterology, UMC Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||Matthijs P Schwartz, PhD, MD||UMC Utrecht|
|Study Director:||Andre J Smout, PhD, MD||UMC Utrecht|