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).

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%).

CONCLUSIONS

The 3-in-1 function of a novel bipolar radiofrequency knife can facilitate POEM with one device.