title: Twelve months' follow-up after treatment with the EndoCinch endoscopic technique for gastro-oesophageal reflux disease: a randomized, placebo-controlled study.
abstract: OBJECTIVE
  The Bard EndoCinch plication technique has been reported to improve symptoms and reduce oesophageal acid exposure in patients with gastro-oesophageal reflux disease (GORD). However, no placebo-controlled studies have been published as yet. The purpose of this study was to evaluate the effects of the EndoCinch plication technique in a randomized, placebo-controlled setting.
  
  
  METHODS
  Forty-six otherwise healthy subjects with objectively verified GORD requiring regular use of proton-pump inhibitors (PPIs) were enrolled in the study. Patients were randomized to the EndoCinch plication technique or a sham procedure. Pre- and post-procedure assessments included gastro-oesophageal endoscopy, oesophageal manometry and 24-h pH recording, quality of life (QoL) assessment and use of PPIs.
  
  
  RESULTS
  Reflux-specific symptoms and use of PPIs (total intake as well as number of patients not taking PPIs) improved in both groups at 6 weeks and at 3 and 12 months post-procedure (p<0.05) with an increased improvement in the treatment group at 3 months compared to controls (p<0.05 versus sham). There were no inter- or intra-group differences in endoscopic findings, oesophageal manometry or acid exposure before or at 3 or 12 months post-procedure. Gastro-oesophageal endoscopy showed that 71% and 67% of sutures remained at 3 and 12 months, respectively.
  
  
  CONCLUSIONS
  Although some short-term effects were achieved, it was found that there were no differences between the treatment and control groups after 12 months and the lack of reduction of oesophageal acid exposure suggests that, in its present form, the EndoCinch plication technique is not to be recommended for use in clinical practice. It is suggested that the lack of long-term effects is primarily due to detachment of the sutures.
authors.affiliation: Division of Surgery, CLINTEC, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden. Madeleine.Montgomery@erstadiakoni.se
authors.forename: Madeleine
authors.initials: M
authors.lastname: Montgomery
authors.forename: Bengt
authors.initials: B
authors.lastname: Håkanson
authors.forename: Olle
authors.initials: O
authors.lastname: Ljungqvist
authors.forename: Bo
authors.initials: B
authors.lastname: Ahlman
authors.forename: Anders
authors.initials: A
authors.lastname: Thorell
mesh_terms: D000328:Adult; D000368:Aged; D004724:Endoscopy / Q000379:methods*; D004947:Esophagus / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000379:methods; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008365:Manometry; D008875:Middle Aged; D054328:Proton Pump Inhibitors; D011788:Quality of Life
chemical_list: D054328:Proton Pump Inhibitors