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% CI = 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.
RCT Entities:
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 GERDpatients 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% CI = 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.
Authors: L Cipolletta; G Rotondano; L Dughera; A Repici; M A Bianco; C De Angelis; A M Vingiani; E Battaglia Journal: Surg Endosc Date: 2005-05-03 Impact factor: 4.584
Authors: C P F Freitag; C R P Kruel; M E S Duarte; P R E Sanches; P R O Thomé; F Fornari; D Driemeier; F Teixeira; R O Mollerke; S M Callegari-Jacques; S G S Barros Journal: Surg Endosc Date: 2008-09-25 Impact factor: 4.584
Authors: Paul Fockens; Lawrence Cohen; Steven A Edmundowicz; Kenneth Binmoeller; Richard I Rothstein; Daniel Smith; Edward Lin; Nicholas Nickl; Bergein Overholt; Peter J Kahrilas; Nimish Vakil; Ayman M Abdel Aziz Hassan; Glen A Lehman Journal: Surg Endosc Date: 2010-03-03 Impact factor: 4.584