Randomized controlled trial comparing the clinical efficacy of a bipolar current knife versus monopolar current knife during esophageal peroral endoscopic myotomy: a multicenter noninferiority study (with video) - 10/12/25

Doi : 10.1016/j.gie.2025.09.055

Salmaan Jawaid, MD ^1,^⁎ , Mohan Ramchandani, MD, DM ², Pradev Inavolu, MD, DM ², Zaheer Nabi, MD, DNB ², Eduardo Albéniz Arbizu, MD ³, Mai Khalaf, MD, MSc ¹, Michael Mercado, CRA ¹, Zacharias Tsiamoulos, MBBS, MD, PhD ⁴, Fares Ayoub, MD ¹, Tara Keihanian, MD, MPH ¹, Haydee Cueto, CRA ¹, Mohamed O. Othman, MD ¹

¹ Division of Gastroenterology, Hepatology and Nutrition, Baylor College of Medicine, Houston, Texas, USA

² Asia Institute of Gastroenterology, Hyderabad, India

³ Navarra Hospital Complex, Navarra, Spain

⁴ Spencer Private Hospital, Margate, UK

^∗ Corresponding author: Salmaan Jawaid, MD, Baylor College of Medicine, 11704 Crescent Bluff Dr, Pearland, Houston, Texas 77030, USA. 11704 Crescent Bluff Dr Pearland Texas 77584 USA

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Wednesday 10 December 2025
Cet article a été publié dans un numéro de la revue, cliquez ici pour y accéder

Abstract

Background and Aims

Use of a novel bipolar current (BC) knife with injection, dissection, and coagulation capability during peroral endoscopic myotomy (POEM) may be advantageous. This randomized controlled trial (RCT) compared the clinical outcomes of BC versus a monopolar current (MC) knife during esophageal POEM (E-POEM).

Methods

A noninferiority RCT study evaluating BC versus MC knife during E-POEM at 3 centers. Primary outcome was technical success: ability to perform the entire procedure with the intended knife.

Results

Technical (96% vs 100%, P = .15) and clinical success (92.7% vs 92.7%) was similar between the BC ( n = 52) and MC knives ( n = 52). Their tunneling speeds (0.65 vs 0.85 cm/min, P = .24) were similar, but procedure times (62.9 vs 53.2 minutes, P = .04, d = 0.41) were slightly shorter in the MC knife group. In addition, 77% of patients in the BC knife group completed the entire procedure with 1 instrument versus none in the MC knife group. Only 1 major adverse event occurred in the BC knife group (managed endoscopically) (1.9%).