Prospective, randomized controlled study evaluating a double-balloon interventional endoscopic platform for colorectal endoscopic submucosal dissection (with video)

Abstract

Backgrounds and aims: Endoscopic submucosal dissection (ESD) can be challenging and time-consuming. A double-balloon interventional platform (DBIP) was designed to assist with navigation, stabilization, traction, and device delivery during complex colorectal polypectomy. We compared traditional ESD (T-ESD) with DBIP-assisted ESD (DBIP-ESD) in a prospective, randomized trial.

Methods: Patients with colorectal polyps ≥2 cm were randomly assigned (1:1) to DBIP-ESD or T-ESD. The primary study endpoint was the mean total procedure time difference between groups. Secondary endpoints were intraprocedural 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% enrollment if the primary endpoint was met (P ≤ .05).

Results: One hundred forty-seven patients were enrolled between February 2019 and February 2020. Seven patients dropped out, and the interim analysis was performed on 140 patients (71 DBIP-ESD, 69 T-ESD). Demographics, comorbidities, and lesion size, location, and classification were similar between groups. The mean procedure time decreased with DBIP-ESD (88.6 ± 42.7 minutes) versus T-ESD (139.5 ± 83.2 minutes; difference of ∼51 minutes [36.5%]; P < .001], with procedural savings of $610.16 (11.4%) per patient after DBIP cost. The DBIP increased dissection speed by 49.0% (15.1 ± 8.0 vs 7.7 ± 6.6 cm²/h, P < .001). En bloc resection was superior with the addition of DBIP (97.2% vs 87.0%, P = .030). The mean navigation time with DBIP-ESD for sutured defect closure decreased by 7.7 minutes (P < .001). There were no adverse events in the DBIP-ESD group.

Conclusions: DBIP-ESD decreased the total procedure time, improved the en bloc resection rate, and facilitated sutured defect closure, making DBIP a promising and cost-effective tool to improve colorectal ESD adoption. (Clinical trial registration number: NCT03846609.).