A new injectable agent for the treatment of GERD: results of the Durasphere pilot trial

Abstract

A variety of endoscopic modalities have been introduced to treat GERD, including radiofrequency energy, suturing, plication, and injection therapy. Our purpose was to assess the long-term safety and effectiveness of Durasphere (Carbon Medical Technologies, St Paul, Minn), a new injectable bulking agent, in the treatment of mild-moderate GERD. Initial human pilot study. Single endoscopy center; study period from January 2005 to August 2006. Ten GERD subjects, confirmed by pH monitoring, on daily proton pump inhibitor (PPI) therapy, hiatal hernia <3 cm, and no or mild erosive esophagitis. Endoscopic injection with Durasphere, a new submucosal bulking agent, at the gastroesophageal junction. Change in symptom scores, PPI use, pH scores, and endoscopic findings; monitoring of safety profile. Nine of 10 patients completed the 12-month trial. There were no adverse events. The procedure was well tolerated with minimal patient discomfort and no dysphagia. At 12 months 70% of patients discontinued all antacid medication completely; 90% of patients reduced PPI use by greater than 50%. DeMeester scores improved from a mean of 44.5 at baseline to 26.5 at 12 months; 4 patients achieved normal pH scores. There was no esophagitis at 12 months, and no erosion, ulceration or sloughing of material was noted at any injection site. The Durasphere material did not appear to migrate. Nonrandomized study design without a control group; small number of subjects. Durasphere appears to be a promising new injectable bulking agent for the treatment of mild-moderate GERD, with demonstrable efficacy and no significant adverse events in a small cohort.