Endoscopic Resolution and Recurrence of Gastric Antral Vascular Ectasia After Serial Treatment with Argon Plasma Coagulation

AIM To evaluate long-term endoscopic resolution and recurrence rate of gastric antral vascular ectasia (GAVE) after argon plasma coagulation (APC) treatment. METHODS This was an IRB-approved retrospective single center study that included patients endoscopically treated for GAVE between 1/1/2008 to 12/31/2014. The primary and secondary end points of the study were rate of endoscopic resolution of GAVE after APC treatment and recurrence rate of GAVE after endoscopic resolution, respectively. Endoscopic resolution of GAVE was defined as no endoscopic evidence of GAVE after treatment with APC. Recurrence of GAVE was defined as endoscopic reappearance of GAVE after prior resolution. RESULTS Twenty patients met the study criteria. Median age (range) of the patients was 59.5 years (42-74 years). GAVE was associated with underlying cirrhosis in 16 (80%) patients. Indications for initial esophagogastroduodenoscopy (EGD) included hematemesis and/or melena (9/20, 45%), iron deficiency anemia (6/20, 30%), screening or surveillance of varices (4/20, 20%), and occult gastrointestinal bleeding (1/20, 5%). The patients were treated with a total of 55 APC sessions (range 1-7 sessions). Successful endoscopic resolution of GAVE was achieved in 8 out of 20 patients (40%). There was no correlation between number of treatment sessions and GAVE treatment success (P = NS). Recurrence of GAVE was noted on a subsequent EGD in 2 out of 8 patients (25%) with prior endoscopic resolution of GAVE. Median follow-up period for the study population was 627 d (range 63-1953 d). CONCLUSION Endoscopic resolution rate of GAVE was low (40%) with a 25% recurrence rate after treatment with APC. These rates suggest that APC treatment of GAVE may not be optimal in many circumstances

Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease

BACKGROUND: This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). METHODS: A prospective, randomized, sham-controlled, single-blinded, international multicenter study planned final enrollment of 204 patients in three groups: up to 60 lead-in, 96 GK, and 48 sham patients. The sham patients were allowed to cross over to the GK treatment arm or exit the study at 6 months. The primary end points were (1) reduction in serious device- and procedure-related adverse device effects compared with a surgical composite complication rate and (2) reduction in heartburn symptoms 6 months after the GK procedure compared with the sham procedure. The secondary end point was improved esophageal pH (total time pH was <4) 6 months after the GK procedure compared with baseline. RESULTS: A planned interim analysis was performed after 143 patients were enrolled (25 lead-in, 75 GK, and 43 sham patients), and the GK study was terminated early due to lack of compelling efficacy data. Four reported serious adverse events had occurred (2 perforations, 1 pulmonary infiltrate related to a perforation, and 1 severe chest pain) at termination of the study with no mortality or long-term sequelae. Heartburn symptoms had improved significantly at 6 months compared with baseline in the GK group (p < 0.0001) and the sham group (p < 0.0001), but no significant between-group difference in improvement was observed (p = 0.146). Esophageal acid exposure had improved significantly at 6 months compared with baseline in the GK group (p = 0.021) and the sham group (p = 0.003), but no significant between-group difference in improvement was observed (p = 0.27). CONCLUSIONS: The GK procedure was associated with some serious but infrequent complications. No statistically significant difference in outcomes was observed between the treatment and control groups at 6 months compared with baseline