title: Endoscopic full-thickness plication (Plicator) with two serially placed implants improves esophagitis and reduces PPI use and esophageal acid exposure.
abstract: OBJECTIVE
  Recently, several endoluminal procedures for the treatment of gastroesophageal reflux disease (GERD) have been introduced. Most of these techniques have been abandoned because they lack long-term efficacy or have serious side effects. In a recently published prospective randomized, sham-controlled trial, the Plicator was shown to be effective at controlling reflux symptoms and esophageal acid exposure. In all previous studies, only a single implant was used. The aim of the present pilot study was to determine the safety and efficacy of two serially placed Plicator implants.
  
  
  METHODS
  Thirty-seven patients requiring maintenance therapy with proton pump inhibitors (PPIs) were enrolled in this single-center pilot study. All patients received two Plicator implants. Exclusion criteria were hiatus hernia larger than 3 cm, grade IV esophagitis, Barrett's esophagus, and esophageal motility disorders. The primary study end point was at least 50 % improvement in the GERD Health-Related Quality of Life (HRQL) score. Secondary end points included GERD medication use, esophageal acid exposure, esophagitis grade, and heartburn/regurgitation scores.
  
  
  RESULTS
  Thirty-seven patients underwent endoscopic full-thickness plication using two serially placed Plicator implants. At 6 months after treatment, the proportion of patients achieving at least 50 % improvement in GERD-HRQL score was 68 %. Complete cessation of PPI treatment was achieved in 59 % of patients. In pH studies conducted at 6 months (n = 29), median percentage of time for which pH was below 4 decreased by 36 %, with 28 % of patients experiencing pH normalization. There were no serious adverse events requiring intervention.
  
  
  CONCLUSIONS
  Endoscopic full-thickness plication using two serially placed Plicator implants was both safe and effective in reducing esophagitis, GERD symptoms, medication use, and esophageal acid exposure.
authors.affiliation: Medizinische Klinik I, Klinikum Ludwigsburg, Ludwigsburg, Germany.
authors.forename: D
authors.initials: D
authors.lastname: von Renteln
authors.forename: U
authors.initials: U
authors.lastname: Brey
authors.forename: B
authors.initials: B
authors.lastname: Riecken
authors.forename: K
authors.initials: K
authors.lastname: Caca
mesh_terms: D000328:Adult; D000368:Aged; D016145:Endoscopy, Digestive System / Q000295:instrumentation / Q000379:methods*; D004942:Esophagitis, Peptic / Q000209:etiology / Q000517:prevention & control*; D004943:Esophagogastric Junction / Q000601:surgery; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D013536:Suture Techniques / Q000295:instrumentation; D013537:Sutures; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors