title: Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial.
abstract: BACKGROUND
  A novel endoscopic full-thickness plication device has been designed to inhibit gastroesophageal reflux by placing a transmural plication near the gastroesophageal junction under direct endoscopic visualization. This study assessed the safety and efficacy of endoscopic full-thickness plication in the treatment of patients with symptoms caused by GERD.
  
  
  METHODS
  Patients with chronic heartburn requiring maintenance therapy with antisecretory medication were recruited. Exclusion criteria were the following: hiatal hernia (>2 cm), grade III and IV esophagitis, and Barrett's esophagus. The following were assessed over a follow-up period of 6 months: GERD-Health-Related Quality of Life, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, medication use, 24-hour esophageal pH monitoring and esophageal manometry. Patients underwent a single, full-thickness plication in the gastric cardia just distal to the gastroesophageal junction. Re-treatment was not permitted.
  
  
  RESULTS
  A total of 64 patients (mean age 46.3 years, range 23-71 years) underwent endoscopic full-thickness plication (mean procedure time 17.2 minutes). At 6 months after plication, proton pump inhibitor therapy had been eliminated in 74% of previously medication-dependent patients. Median GERD-Health-Related Quality of Life scores improved 67% (19.0 vs. 5.0; p<0.001). Improvements also were observed in median Gastrointestinal Symptom Rating Scale and SF-36 Health Survey mental and physical composite scores. Median esophageal acid exposure improved significantly (10 vs. 8; p<0.008) with normalization of pH noted in 30% of patients. No significant change in esophageal manometry was noted. One gastric perforation occurred and was managed conservatively without sequelae.
  
  
  CONCLUSIONS
  In this study, a single full-thickness plication placed at the gastroesophageal junction reduced symptoms, medication use, and esophageal acid exposure associated with GERD.
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Pleskow
authors.forename: Richard
authors.initials: R
authors.lastname: Rothstein
authors.forename: Simon
authors.initials: S
authors.lastname: Lo
authors.forename: Robert
authors.initials: R
authors.lastname: Hawes
authors.forename: Richard
authors.initials: R
authors.lastname: Kozarek
authors.forename: Gregory
authors.initials: G
authors.lastname: Haber
authors.forename: Christopher
authors.initials: C
authors.lastname: Gostout
authors.forename: Anthony
authors.initials: A
authors.lastname: Lembo
mesh_terms: D000328:Adult; D000368:Aged; D002299:Cardia; D016145:Endoscopy, Digestive System / Q000295:instrumentation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D011788:Quality of Life