Clinical Experience With a Double Balloon Interventional Endoscopic Platform to Facilitate Colonic Endoscopic Submucosal Dissection, Endoscopic Mucosal Resection and Endoscopic Suturing: First 137 Procedures: Presidential Poster Award

Abstract

Introduction: Endoscopic submucosal dissection (ESD) is gaining popularity worldwide. Despite clinical advantages of ESD over piecemeal endoscopic mucosal resection (EMR), colonic ESD remains technically challenging, labor-intensive and time-consuming. New endolumenal interventional platform (Lumendi LLC, USA) consists of overtube with 2 manually inflatable balloons and compatible with most standard endoscopes. Methods: Colonoscope with preloaded device was advanced into colon. The “fore-balloon” was advanced beyond colonic lesion and then both balloons were inflated stabilizing the lesion inside “therapeutic zone” between balloons. ESD or EMR was performed. After lesion resection, colonoscope was removed and a double channel endoscope loaded with endoscopic suturing device (Apollo Endosurgery, USA) was inserted through the platform to perform endoscopic suturing closure of large mucosal defect post ESD/EMR. Results: From November 2017 till April 2018 the device was used in consecutive patients with large (mean size 35.0±19.7 mm) lesions located in cecum (38), ascending colon (58), hepatic flexure (13), transverse colon (10), descending colon (4), sigmoid (9) and rectum (2). Majority (126 lesions, 92%) were removed by ESD, and only 11 lesions (8%) were removed by EMR. En bloc resection rate in EMR group was only 18.2%. En bloc resection rate in ESD group was 87.1%. Advancement of colonoscope preloaded with the device to reach colonic lesion was successful in all cases, requiring 10.0±8.3 minutes. Stabilization of the lesions by the balloons facilitated endoscopic intervention (mean intervention time 45.0 ±40.6 minutes), enabled quick advancement and closure of the defect utilizing the suturing device (mean advancement time 2.5±2.9 minutes, mean closure time 13.3±8.7 minutes). Total procedure time was 70.6±24.9 minutes. There were no device or procedure related serious adverse events during the study. Conclusion: This new interventional platform appears safe, effective and easy to use. Stabilization of colonic lesions with deployed balloons markedly facilitated colonic ESD and EMR, simplified suturing closure of large mucosal defects post lesion removal and significantly shortened the total procedure time. Retrospective and prospective case matched studies will be performed to better quantify the time benefit. The device has the potential to expand the number of complex benign polyps that can be handled endoscopically vs. surgically.