Use of an Endoscopic Suturing Device (the ”ESD”) to Treat Patients with Gastroesophageal Reflux Disease, After Unsuccessful EndoCinch Endoluminal Gastroplication: Another Failure

Abstract

Endoluminal gastroplication, using the EndoCinch procedure, has emerged as a potential endoscopic antireflux therapy. Although initial results have been promising, the long-term durability of the treatment is uncertain due to suture loss. A new endoscopic suturing device, the "ESD," has been developed that promises excellent visibility and endoscopic control. The aim of this study was to evaluate prospectively the feasibility and efficacy of the ESD method after EndoCinch failure. The study involved 20 patients with gastroesophageal reflux disease (GERD), who had been initially treated with an EndoCinch procedure, but had relapsed after a median of 7.5 months, with lost or dysfunctional sutures and with reflux symptoms that required proton pump inhibitor (PPI) treatment. Using the ESD, at least three plications were created at the gastroesophageal junction. Patients underwent endoscopy, 24-hour pH monitoring and esophageal manometry before treatment and 6 months afterwards. In addition, reflux symptoms as well as quality-of-life scores were assessed (using the SF-6 and GERD-HRQL scales). The ESD procedure (median procedure time 45 min) was performed successfully in all patients without major complications. After 6 months only one patient (5 %) still had all sutures in situ, while no remaining sutures could be detected in 3/20 (15 %). No significant changes in reflux esophagitis; 24-hour pH monitoring results (median pH < 4/24 h9.9 % vs. 12.3 %; P = 0.60); manometry findings (median lower esophageal sphincter pressure 7.2 mm Hg vs. 9.9 mm Hg; P = 0.22); PPI use; or reflux esophagitis could be detected after 6 months. While reflux symptoms improved (heartburn severity score 30 vs. 48, P < 0,05), no changes in quality-of-life scores were detected. Endoluminal gastroplication using the ESD is an easy and safe, but unfortunately ineffective procedure for endoscopic GERD treatment. Endoluminal gastroplication techniques clearly need refinements before these therapies can evolve as a treatment option for GERD patients.