55 - Similar Efficacy of a Novel Bipolar Radiofrequency Ablation Knife to Monopolar Current Knife in Endoscopic Submucosal Dissection of Colonic Lesions: A Non-Inferiority Randomized Trial
Mai A. Khalaf, MD1, Al sayed Wasfy, 2, Sabry Abosaif, 2, Mohamed Yousef, 2, Michael Mercado, 1, Tara Keihanian, MD1, Salmaan A. Jawaid, MD1, Mohamed O. Othman, MD1 1Baylor College of Medicine, Houston, TX; 2Tanta University, Tanta, Al Gharbiyah, Egypt
Introduction: Monopolar current knives (MC) are commonly used for Endoscopic Submucosal Dissection (ESD) but variations in tissue composition and consistency can limit their effectiveness. To overcome these challenges, a novel bipolar radiofrequency ablation (RFA) cutting knife (BC), was developed. This randomized controlled trial aims to evaluate the efficacy of the BC vs MC during colonic ESD.
Methods: We conducted a non-inferiority trial at a single US referral center to evaluate a new bipolar ESD knife for colonic ESD. Inclusion criteria were G-LST ≥ 30 mm or non-GLST lesions ≥ 20mm, while ICV, appendix lesions, and pedunculated polyps were excluded. Randomization was done using computer software. The primary outcome was successful completion of dissection with the intended knife and technical success (en bloc/R0 resection rates). Secondary endpoints included dissection speed and post-procedure pain scores.
Results: In this study, 70 patients with a total of 72 polyps were included. The Bipolar Current (BC) group had 37 patients, while the Monopolar Current (MC) group had 33 patients (Table 1). Most patients (87.1% in BC and 100% in MC) were treated with a single knife (p=0.7). Five patients required knife change due to limited rotation of the bipolar knife and intraprocedural bleeding. In the MC group, all patients required an additional instrument for injection, unlike the BC group where only 14.7% needed it (P=0.05). The use of traction or stabilization devices did not significantly differ between the groups (p=0.52 vs. 0.15).
Similar findings were observed when crossover cases were excluded. Both groups demonstrated comparable en bloc resection rates (97%, p=1) and R0 resection rates (90.1% vs. 97%, p=0.85). Dissection speed was similar between the groups, and there were no significant differences in pain scores at 1 hour and 24 hours post-procedure (24-hour pain scores: 1.8 ± 2.5 in BC vs. 0.8 ± 2.3 in MC, p=0.14).
Discussion: The bipolar ESD knife showed comparable technical success, en bloc resection, R0 resection, dissection speed, and post-procedural pain scores compared to the monopolar knife, the bipolar knife has the advantage of performing submucosal injection, dissection, and coagulation without requiring instrument or catheter switching. However, it has limitations in challenging locations or vascular lesions. Additional studies are required to assess if the bipolar knife enhances resource allocation compared to the monopolar knife.
Table: Demographic characteristics and procedural outcomes of the study groups
Disclosures: Mai Khalaf indicated no relevant financial relationships. Al sayed Wasfy indicated no relevant financial relationships. Sabry Abosaif indicated no relevant financial relationships. Mohamed Yousef indicated no relevant financial relationships. Michael Mercado indicated no relevant financial relationships. Tara Keihanian: ConMed – Consultant. Lumendi – Consultant. Neptune Medical – Consultant.Salmaan Jawaid: Boston Scientific – Consultant. ConMed – Consultant. CREO Speedboat – Consultant. DiLumen – Consultant.Mohamed Othman: AbbVie Inc. – Consultant, Grant/Research Support. Apollo – Consultant. Boston Scientific Coporation – Consultant, Grant/Research Support. ConMed – Consultant, Grant/Research Support. Creo Medical – Consultant. Lucid Diagnostics – Grant/Research Support. Lumendi – Consultant. Olympus – Consultant.
Mai A. Khalaf, MD1, Al sayed Wasfy, 2, Sabry Abosaif, 2, Mohamed Yousef, 2, Michael Mercado, 1, Tara Keihanian, MD1, Salmaan A. Jawaid, MD1, Mohamed O. Othman, MD1, 55, Similar Efficacy of a Novel Bipolar Radiofrequency Ablation Knife to Monopolar Current Knife in Endoscopic Submucosal Dissection of Colonic Lesions: A Non-Inferiority Randomized Trial, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.
