Endoscopic implantation of Enteryx for treatment of GERD

12-Month results of a prospective, multicenter trial

David A. Johnson, Robert Ganz, James Aisenberg, Lawrence B. Cohen, Jacques Devière, T. Raymond Foley, Gregory B. Haber, Jeffrey H. Peters, Glen Lehman

Research output: Contribution to journalArticle

123 Citations (Scopus)

Abstract

OBJECTIVES: This study aimed to assess the efficacy and safety of endoscopically implanting a nonresorbable biocompatible polymer (Enteryx) in the distal esophagus and proximal gastric cardia for the treatment of gastroesophageal reflux disease (GERD). METHODS: In a prospective, multicenter, international trial, 85 well-controlled GERD patients who were receiving chronic proton pump inhibitor (PPI) therapy underwent Enteryx implantation under fluoroscopic visualization, without general anesthesia. After the procedure, patients were discharged within approximately 2-4 h. Patients were judged to be treatment responders if after implantation they reduced PPI dosage by ≥50%. Follow-up evaluations were conducted at 1, 3, 6, and 12 months and included medication usage, symptoms, quality of life, endoscopy, pH monitoring, manometry, and documentation of adverse events. RESULTS: At 12 months, 80.3% (95% Cl = 69.9% 88.3%) of 81 evaluable patients were treatment responders. Of the responders, 87.7% completely discontinued PPIs, and 12.3% reduced PPI dosage by ≥50%. Treatment response was more likely in patients with residual implant volume of ≥5 mL (p = 0.027). Other patient and treatment variables were not predictive. Both GERD heartburn and regurgitation symptom scores significantly improved at 12 months compared with baseline (p <0.001). There were significant reductions in median supine, upright, and total percent time of esophageal exposure to pH

Original languageEnglish (US)
Pages (from-to)1921-1930
Number of pages10
JournalAmerican Journal of Gastroenterology
Volume98
Issue number9
DOIs
StatePublished - Sep 1 2003
Externally publishedYes

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Gastroesophageal Reflux
Multicenter Studies
Proton Pump Inhibitors
Therapeutics
Heartburn
Cardia
Residual Volume
Manometry
Documentation
General Anesthesia
Esophagus
Endoscopy
ethylene-vinyl alcohol copolymer
Stomach
Polymers
Quality of Life
Safety

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Endoscopic implantation of Enteryx for treatment of GERD : 12-Month results of a prospective, multicenter trial. / Johnson, David A.; Ganz, Robert; Aisenberg, James; Cohen, Lawrence B.; Devière, Jacques; Foley, T. Raymond; Haber, Gregory B.; Peters, Jeffrey H.; Lehman, Glen.

In: American Journal of Gastroenterology, Vol. 98, No. 9, 01.09.2003, p. 1921-1930.

Research output: Contribution to journalArticle

Johnson, David A. ; Ganz, Robert ; Aisenberg, James ; Cohen, Lawrence B. ; Devière, Jacques ; Foley, T. Raymond ; Haber, Gregory B. ; Peters, Jeffrey H. ; Lehman, Glen. / Endoscopic implantation of Enteryx for treatment of GERD : 12-Month results of a prospective, multicenter trial. In: American Journal of Gastroenterology. 2003 ; Vol. 98, No. 9. pp. 1921-1930.
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