PROSPECTIVE, RANDOMIZED CONTROLLED STUDY EVALUATING DOUBLE BALLOON INTERVENTIONAL ENDOSCOPIC PLATFORM FOR COLORECTAL ESD

Abstract

Endoscopic submucosal dissection (ESD) can be challenging/time-consuming. A Double Balloon Interventional Platform (DBIP) was designed to assist with navigation, stabilization, traction and device delivery during complex colorectal polypectomy. to compare traditional (T-ESD) to DBIP-assisted ESD (DBIP-ESD) in a prospective, randomized trial. Patients with colorectal polyps ≥ 2 cm were randomly assigned (1:1) to DBIP-ESD or T-ESD. Primary study endpoint: mean total procedure time difference between groups. Secondary endpoints: intra-procedural time-points, en bloc resection rate, procedure cost, adverse events, and 3-month assessment. A sample size of 200 subjects for ≥ 80% power was calculated. Interim analysis for early study termination was planned at 70% enrolment if primary endpoint was met (p ≤ 0.05). 147 patients were enrolled between February 2019-February 2020. Seven patients dropped out. Interim analysis was performed on 140 patients (71 DBIP-ESD, 69 T-ESD). Demographics, co-morbidities, lesion size/location/classification were similar between groups. Mean procedure time decreased with DBIP (88.6±42.7 min) vs. T-ESD (139.5±83.2 min), [51 minutes, 36.5%, p<0.001], with procedural savings of $760.16 (14%) per patient after DBIP cost. DBIP increased dissection speed by 49.0% (15.1±8.0 vs 7.7±6.6 cm2/hour, p< 0.001). En bloc resection was superior with DBIP (97.2% vs 87.0%, p=0.030). Mean navigation time with DBIP for sutured defect closure decreased by 7.7 minutes (p<0.001). There were no adverse events in the DBIP group. DBIP decreased total procedure time, improved en bloc resection rate, facilitated sutured defect closure, making DBIP a promising and cost-effective tool to improve colorectal ESD adoption.