Impact of electrical pulse cut mode during endoscopic papillectomy: Pilot randomized clinical trial
| Autor: | Kenjiro Yamamoto, Takashi Seino, Tadashi Katayama, Takao Itoi, Yujiro Machida, Ryosuke Tonozuka, Shujiro Tsuji, Seiichiro Fukuhara, Kazuhiro Minami, Minoru Kitago, Atsushi Sofuni, Reina Tanaka, Takayoshi Tsuchiya, Masayasu Horibe, Eisuke Iwasaki, Shintaro Kawasaki, Yoichi Takimoto, Haruhiko Ogata, Hiroki Tamagawa, Takanori Kanai |
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| Rok vydání: | 2019 |
| Předmět: |
Adenoma
Male medicine.medical_specialty Ampulla of Vater Electrosurgery medicine.medical_treatment Common Bile Duct Neoplasms Endoscopic mucosal resection Pilot Projects law.invention 03 medical and health sciences Sphincterotomy Endoscopic 0302 clinical medicine Randomized controlled trial law Multicenter trial medicine Humans Radiology Nuclear Medicine and imaging Single-Blind Method Prospective Studies Duodenoscopy Aged business.industry Incidence (epidemiology) Gastroenterology Middle Aged medicine.disease Surgery Clinical trial 030220 oncology & carcinogenesis Pancreatitis 030211 gastroenterology & hepatology Female business |
| Zdroj: | Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy SocietyReferences. 32(1) |
| ISSN: | 1443-1661 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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