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Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial
  1. M P Schwartz1,
  2. H Wellink1,
  3. H G Gooszen2,
  4. J M Conchillo1,
  5. M Samsom1,
  6. A J P M Smout1
  1. 1Department of Gastroenterology, University Medical Centre, Utrecht, The Netherlands
  2. 2Department of Surgery, University Medical Centre, Utrecht, The Netherlands
  1. Correspondence to:
    Dr M P Schwartz
    Department of Gastroenterology, University Medical Centre, PO Box 85500, 3508 GA Utrecht, The Netherlands; m.p.schwartz{at}umcutrecht.nl

Abstract

Background: Endoscopic treatment for gastro-oesophageal reflux disease (GORD) is rapidly emerging, but there is a great need for randomised controlled trials to evaluate the efficacy.

Design and setting: A single-centre, double-blind, randomised, sham-controlled trial of endoscopic gastroplication by the Endocinch suturing system.

Patients and interventions: 60 patients with GORD were randomly assigned to three endoscopic gastroplications (n = 20), a sham procedure (n = 20) or observation (n = 20). The research nurse and patients in the active and sham groups were blinded to the procedure assignment. After 3 months, open-label active treatment was offered to all patients.

Outcome measures: The primary outcome measures were proton pump inhibitor (PPI) use and GORD symptoms, and secondary measures were quality of life, 24-h oesophageal acid exposure, oesophageal manometry and adverse events. Follow-up assessments were performed at 3, 6 and 12 months.

Results: At 3 months, the percentage of patients who had reduced drug use by ⩾50% was greater in the active treatment group (65%) than in the sham (25%) or observation groups (0%) (p<0.02). Symptoms (heartburn and to a lesser extent regurgitation) improved more in the active group than in the sham group. Three Short Form-20 quality of life subscales (role function, general health and bodily pain perception) improved in the active group versus sham. Oesophageal acid exposure was modestly decreased after active treatment (p<0.02), but not significantly greater than after the sham procedure (p = 0.61). The active treatment effects on PPI use, symptoms and quality of life persisted after 6 and 12 months of open-label follow-up (n = 41), but 29% of patients were retreated in this period. No serious adverse events occurred.

Conclusions: Endoscopic gastroplication, using the Endocinch device, reduced acid-inhibitory drug use, improved GORD symptoms and improved the quality of life at 3 months compared with a sham procedure. The effects persisted up to 12 months. However, the reduction in oesophageal acid exposure was not greater after endoscopic treatment than after a sham procedure.

  • ANOVA, analysis of variance
  • GORD, gastro-oesophageal reflux disease
  • IQR, interquartile range
  • LOS, lower oesophageal sphincter
  • OGJ, oesophagogastric junction
  • PPI, proton pump inhibitor
  • SF-20, Short Form-20
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Footnotes

  • Published Online First 8 June 2006

  • Competing interests: HW was supported by a grant from Janssen-Cilag pharmaceuticals.

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