title: Effect of endoscopic augmentation of the lower oesophageal sphincter (Gatekeeper reflux repair system) on intraoesophageal dynamic characteristics of acid reflux.
abstract: OBJECTIVE
  Improvements in symptoms following endoscopic procedures for gastro-oesophageal reflux disease (GORD) are seldom supported by normalisation of acid exposure time at the distal oesophagus. However, the distribution of gastric acid within the proximal oesophagus is a main determinant of symptom generation in GORD patients. In this study, our aim was to assess the effect of endoscopic insertion of hydrogel expandable prostheses into the oesophageal submucosa on spatiotemporal characteristics of gastro-oesophageal reflux.
  
  
  METHODS
  Oesophageal manometry and multichannel ambulatory 24 hour pH monitoring were carried out in nine patients before and six months after the endoscopic procedure. Dynamic characteristics of gastro-oesophageal reflux in patients were also compared with those in 13 asymptomatic controls.
  
  
  RESULTS
  Acid exposure time (AET) at the distal oesophagus decreased from 11.7% (95% confidence interval 6.1-21.8) at baseline to 7.7% (3.7-11.6) at follow up (NS). Of the nine patients, distal AET normalised in three. AET at the middle (7.6% (2.9-12.3)) and proximal (2.4% (0.1-4.8)) oesophagus decreased significantly in all patients (2.4% (0.3-4.5), p <0.01; 1.2% (0.2-2.2), p<0.05 respectively). Proximal extent of acid events significantly decreased in all patients at follow up (37.3% v 9.5%), reaching values observed in asymptomatic controls. Median GORD health related quality of life scores significantly improved from 35.5 at baseline to 9.4.
  
  
  CONCLUSIONS
  Despite the lack of a significant improvement in traditional pH variables, endoscopic implant of hydrogel prostheses above the lower oesophageal sphincter significantly decreases proximal spread of acid reflux into oesophageal body. This effect would explain the improvement in symptoms in patients six months after therapy.
authors.affiliation: Department of Digestive Disease, University Campus Bio Medico, Rome (Italy). m.cicala@unicampus.it
authors.forename: M
authors.initials: M
authors.lastname: Cicala
authors.forename: A
authors.initials: A
authors.lastname: Gabbrielli
authors.forename: S
authors.initials: S
authors.lastname: Emerenziani
authors.forename: M P L
authors.initials: MP
authors.lastname: Guarino
authors.forename: M
authors.initials: M
authors.lastname: Ribolsi
authors.forename: R
authors.initials: R
authors.lastname: Caviglia
authors.forename: G
authors.initials: G
authors.lastname: Costamagna
mesh_terms: D000328:Adult; D004947:Esophagus / Q000503:physiopathology*; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000503:physiopathology / Q000601:surgery*; D005773:Gastroscopy; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D006863:Hydrogen-Ion Concentration; D008297:Male; D008365:Manometry; D008875:Middle Aged; D019736:Prostheses and Implants; D019919:Prosthesis Implantation / Q000379:methods; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D020136:Hydrogel, Polyethylene Glycol Dimethacrylate