Endoscopic augmentation of the lower esophageal sphincter for the treatment of gastroesophageal reflux disease: multicenter study of the Gatekeeper Reflux Repair System.

Fockens, P; Bruno, MJ; Gabbrielli, A; Odegaard, S; Hatlebakk, J; Allescher, HD; Rösch, T; Rhodes, M; Bastid, C; Rey, J; Boyer, J; Muehldorffer, S; van den Hombergh, U; Costamagna, G

doi:10.1055/s-2004-825665

2004

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Title:: Endoscopic augmentation of the lower esophageal sphincter for the treatment of gastroesophageal reflux disease: multicenter study of the Gatekeeper Reflux Repair System.
Document type:: Clinical Trial; Journal Article; Multicenter Study
Author(s):: Fockens, P; Bruno, MJ; Gabbrielli, A; Odegaard, S; Hatlebakk, J; Allescher, HD; Rösch, T; Rhodes, M; Bastid, C; Rey, J; Boyer, J; Muehldorffer, S; van den Hombergh, U; Costamagna, G
Abstract:: BACKGROUND AND STUDY AIMS: The safety and effectiveness of the Gatekeeper Reflux Repair System (Medtronic Europe, Tolochenaz, Switzerland) in the treatment of gastroesophageal reflux disease (GERD) was evaluated. This new, reversible treatment modality involves the endoscopic introduction of expandable polyacrylonitrile-based hydrogel prostheses into the esophageal submucosa to augment the lower esophageal sphincter (LES). PATIENTS AND METHODS: For this study, data from two prospective, nonrandomized European multicenter trials were pooled. Sixty-nine GERD patients with heartburn and regurgitation and abnormal esophageal acid exposure (24-h pH < 4.0 for > 4 % of the total time) who had responded to proton-pump inhibitor (PPI) therapy were recruited, and 68 were treated with up to six prostheses placed at the gastroesophageal junction. Patients underwent esophageal manometry, endoscopy, 24-h pH-metry, and symptom scoring at intake and 1, 3, and 6 months after the procedure. RESULTS: A total of 77 procedures were performed in 67 patients, and a total of 270 prostheses were placed (mean 4.3 per procedure). At 1 and 6 months, 80.4 % and 70.4 % of the prostheses were retained, respectively. At 6 months, 24-h pH-metry outcomes with pH < 4.0 for > 4.0 % of the time decreased from 9.1 % to 6.1 % (n = 45; P < 0.05). Median LES pressure increased significantly from 8.8 mmHg at baseline to 13.8 mmHg at 6 months (n = 42, P < 0.01). Median GERD heartburn-related quality-of-life scores improved significantly from 24.0 to 5.0 (n = 53, P < 0.01) in patients no longer receiving PPI therapy. Two serious adverse events (3.0 %) occurred. Both patients recovered uneventfully. Prostheses were endoscopically removed from one patient without any adverse events. CONCLUSIONS: The Gatekeeper Reflux Repair System is a safe endoscopic treatment modality that significantly improves GERD symptoms and has objective effects on acid reflux.
Journal title abbreviation:: Endoscopy
Year:: 2004
Journal volume:: 36
Journal issue:: 8
Pages contribution:: 682-9
Language:: eng
Fulltext / DOI:: doi:10.1055/s-2004-825665
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/15280972
Print-ISSN:: 0013-726X
TUM Institution:: II. Medizinische Klinik und Poliklinik (Gastroenterologie)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin II, Gastroenterologie (Prof. Schmid)2004