Spray and Forced Coagulation Mode Endoscopic Submucosal Dissection for Early Gastric Neoplasms: A Multicenter Randomized Controlled Trial.

Abstract

Introduction: Controlling intraoperative bleeding during endoscopic submucosal dissection (ESD) is essential to ensure the safety and reliability of the procedure. ESD in spray coagulation mode (SCM-ESD) is expected to ensure more effective bleeding control. The aim of this study was to investigate the superiority of SCM-ESD over conventional forced coagulation mode ESD (FCM-ESD) in hemostatic ability for treating early gastric neoplasms (EGNs).

Methods: This multicenter randomized controlled trial (Spray-G Trial) was conducted at 5 Japanese institutions. Patients with intramucosal EGNs were enrolled and randomly assigned to either the SCM-ESD or FCM-ESD group. The primary outcome was ESD completion with an electrosurgical knife alone, that is, without the use of hemostatic forceps. The number and duration of hemostatic procedures using hemostatic forceps, procedure time, curability, and adverse events were also evaluated.

Results: Each group included 65 patients. The rate of ESD completion without using hemostatic forceps was significantly higher for SCM-ESD than for FCM-ESD (83.1% vs 13.8%, P < 0.0001). SCM-ESD and FCM-ESD did not differ significantly in procedure time (48.3 minutes vs 56.0 minutes, P = 0.1071), R0 resection (100% vs 95.4%, P = 0.2442), and rate of adverse events (3.1% vs 6.2%, P = 0.6801).

Discussion: SCM-ESD significantly improved ESD completion rates for intramucosal EGNs without using hemostatic forceps. SCM-ESD is a promising technique that may streamline ESD by eliminating the need to exchange devices and reducing costs (UMIN Clinical Trials Registry, Numbers: UMIN000047353).