Randomized Controlled Trial Comparing the Clinical Efficacy of a Bipolar Current Knife versus Monopolar Current Knife During Esophageal PerOral Endoscopic Myotomy: A Multicenter Non-inferiority Study.

IF 7.5 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gastrointestinal endoscopy Pub Date : 2025-10-09 DOI:10.1016/j.gie.2025.09.055

Salmaan Jawaid, Mohan Ramchandani, Pradev Inavolu, Zaheer Nabi, Eduardo Albéniz Arbizu, Mai Khalaf, Michael Mercado, Zacharias Tsiamoulos, Fares Ayoub, Tara Keihanian, Haydee Cueto, Mohamed O Othman

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Abstract

Background and aims: With injection, dissection and coagulation capability, use of a novel BC (Bipolar Current Knife) during POEM may be advantageous. This randomized controlled trial (RCT) compared the clinical outcomes of BC vs MC (Monopolar Current Knife) during E-POEM.

Methods: A non-inferiority RCT study evaluating BC vs MC during E-POEM at three centers. Primary outcome was technical success: ability to perform the entire procedure with the intended knife.

Results: Technical (96% vs 100%, p=0.15) and clinical success (92.7% vs 92.7%) was similar between BC (n=52)/MC (n=52). Tunneling speed (0.65 vs 0.85 cm/min, p=0.24) was similar but procedure times (62.9 vs 53.2, p=0.04, D= 0.41) were slightly shorter in MC. 77% of patients in BC completed the entire procedure with one instrument vs none in MC. Only one major adverse event occurred in BC (managed endoscopically) (1.9%) CONCLUSION: The 3-in-1 function of a novel bipolar RFA knife can facilitate POEM with one device.

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比较双极电流刀与单极电流刀在食管经口内窥镜肌切开术中的临床疗效的随机对照试验：一项多中心非效性研究。

背景和目的：由于具有注射、解剖和凝血能力，在POEM中使用新型BC（双极电流刀）可能是有利的。这项随机对照试验（RCT）比较了BC和MC（单极电流刀）在E-POEM中的临床结果。方法：在三个中心进行非劣效性随机对照研究，评估E-POEM中BC与MC的差异。主要结果是技术上的成功：能够用预定的刀完成整个手术。结果：BC (n=52)/MC （n=52）患者的技术成功率（96% vs 100%, p=0.15）和临床成功率（92.7% vs 92.7%）相似。隧道速度（0.65 vs 0.85 cm/min, p=0.24）相似，但手术时间（62.9 vs 53.2, p=0.04， D= 0.41）在MC中略短。77%的BC患者使用一个器械完成了整个手术，而MC中没有。BC中仅发生了一个主要不良事件（内窥镜管理）（1.9%）。结论：新型双极RFA刀的三合一功能可以促进POEM使用一个装置。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gastrointestinal endoscopy 医学-胃肠肝病学

CiteScore

10.30

自引率

7.80%

发文量

1441

审稿时长

38 days

期刊介绍： Gastrointestinal Endoscopy is a journal publishing original, peer-reviewed articles on endoscopic procedures for studying, diagnosing, and treating digestive diseases. It covers outcomes research, prospective studies, and controlled trials of new endoscopic instruments and treatment methods. The online features include full-text articles, video and audio clips, and MEDLINE links. The journal serves as an international forum for the latest developments in the specialty, offering challenging reports from authorities worldwide. It also publishes abstracts of significant articles from other clinical publications, accompanied by expert commentaries.