Impact of electrical pulse cut mode during endoscopic papillectomy: Pilot randomized clinical trial

Abstract

ObjectiveEndoscopic papillectomy is increasingly being used for ampullary adenoma treatment. However, it remains challenging despite increased safety with treatment advances. The ideal power output and electrosurgical current mode for mucosal resection are not established. We aimed to identify the ideal electrical pulse for use during resection.MethodsThis pilot randomized, single‐blind, prospective, multicenter trial, recruited patients with ampullary adenomas and conventional anatomy who were scheduled to undergo endoscopic papillectomy. Endoscopic treatment was performed using a standardized algorithm and patients were randomized for endoscopic papillectomy with Endocut or Autocut. The primary outcome was the incidence of delayed bleeding. Incidence of procedure‐related pancreatitis, successful complete resection, pathological findings, and other adverse events were secondary endpoints.ResultsSixty patients were enrolled over a 2‐year period. The incidences of delayed bleeding (13.3% vs. 16.7%, P = 1.00) and pancreatitis (27% vs. 30%, P = 0.77) were similar between both groups. The rate of crush artifacts was higher in the Endocut than in the Autocut group (27% vs. 3.3%, P = 0.03). Immediate bleeding when resecting tumors greater than 14 mm in diameter was more common in the Autocut than in the Endocut group (88% vs. 46%, P = 0.04).ConclusionsThe Autocut and Endocut modes have similar efficacy and safety for endoscopic papillectomy. The Endocut mode may prevent immediate bleeding in cases with large tumor sizes, although it causes more frequent crush artifacts.Registry and the registration numberThe Japanese UMIN Clinical Trials Registry (UMIN‐CTR: 000021382).

Can prophylactic argon plasma coagulation reduce delayed post‐papillectomy bleeding? A prospective multicenter trial

“…Another consideration is that electrosurgical current mode for mucosal resection can affect bleeding after papillectomy. Iwasaki et al 31 . showed that the Endocut mode may prevent immediate bleeding in cases with large tumor sizes, albeit at the cost of more frequent crush artifacts.…”

Endoscopic management of ampullary tumors: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

“…The rate of crush artefacts was higher in the endocut than in the autocut group (27 % vs. 3.3 %, P = 0.03). Immediate bleeding when tumors greater than 14 mm in diameter were resected was more common in the autocut than in the endocut group (88 % vs. 46 %, P = 0.04) [169].…”

“…In a retrospective case-control trial focusing on adverse events with respect to technical modifications of papillectomy, the use of endocut instead of pure cutting current resulted in a significant reduction of early bleeding without any consequence observed in terms of cannulation rate of the pancreatic orifice and post-ERCP pancreatitis rate [154]. Iwasaki et al [169] in an RCT demonstrated that although both pure cutting current (autocut mode) and blended cutting current (endocut mode) have similar efficacy and safety for endoscopic papillectomy, the endocut mode may prevent immediate bleeding in cases with large tumor sizes. In this study, 60 patients were enrolled over a 2-year period.…”

A Novel Technique of Endoscopic Papillectomy with Hybrid Endoscopic Submucosal Dissection for Ampullary Tumors: A Proof-of-Concept Study (with Video)

“…In our series, the vertical margin was uncertain in three cases due to the burning effects but no tumor recurrence was observed after a median follow-up of 244 days. In a pilot randomized controlled trial comparing electrical pulse cut mode, the Autocut mode without coagulation might prevent these burning effects and allow better pathological evaluation [21].…”