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 A. Lehman

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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 <4. Endoscopically assessed esophagitis grades were unchanged. No serious adverse events were encountered. Transient retrosternal chest pain was experienced by 91.8% of patients. This pain was seldom severe and was typically successfully managed with prescription pain medication. CONCLUSIONS: Enteryx implantation allows most patients to discontinue PPI therapy, improves their symptoms, and reduces esophageal acid exposure. The effects of implantation are long-lasting, and morbidity is transient and minimal. The procedure requires basic endoscopic skills and seems to provide a useful option in the effective clinical management of GERD.

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

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ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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Johnson, D. A., Ganz, R., Aisenberg, J., Cohen, L. B., Devière, J., Foley, T. R., Haber, G. B., Peters, J. H., & Lehman, G. A. (2003). Endoscopic implantation of Enteryx for treatment of GERD: 12-Month results of a prospective, multicenter trial. American Journal of Gastroenterology, 98(9), 1921-1930. https://doi.org/10.1111/j.1572-0241.2003.08109.x