OBJECTIVE:Endoscopic 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. METHODS: This 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. RESULTS:Sixty 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). CONCLUSIONS: The 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 NUMBER: The Japanese UMIN Clinical Trials Registry (UMIN-CTR: 000021382).
RCT Entities:
OBJECTIVE: Endoscopic 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. METHODS: This 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. RESULTS: Sixty 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). CONCLUSIONS: The 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 NUMBER: The Japanese UMIN Clinical Trials Registry (UMIN-CTR: 000021382).
Authors: Andrew M Veitch; Franco Radaelli; Raza Alikhan; Jean-Marc Dumonceau; Diane Eaton; Jo Jerrome; Will Lester; David Nylander; Mo Thoufeeq; Geoffroy Vanbiervliet; James R Wilkinson; Jeanin E van Hooft Journal: Endoscopy Date: 2021-08-06 Impact factor: 10.093
Authors: Jeska A Fritzsche; Paul Fockens; Marc Barthet; Marco J Bruno; David L Carr-Locke; Guido Costamagna; Gregory A Coté; Pierre H Deprez; Marc Giovannini; Gregory B Haber; Robert H Hawes; Jong Jin Hyun; Takao Itoi; Eisuke Iwasaki; Leena Kylänpaä; Horst Neuhaus; Jeong Youp Park; D Nageshwar Reddy; Arata Sakai; Michael J Bourke; Rogier P Voermans Journal: Gastrointest Endosc Date: 2021-04-19 Impact factor: 9.427
Authors: Andrew M Veitch; Franco Radaelli; Raza Alikhan; Jean Marc Dumonceau; Diane Eaton; Jo Jerrome; Will Lester; David Nylander; Mo Thoufeeq; Geoffroy Vanbiervliet; James R Wilkinson; Jeanin E Van Hooft Journal: Gut Date: 2021-09 Impact factor: 23.059