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

Eisuke Iwasaki, Kazuhiro Minami, Takao Itoi, Kenjiro Yamamoto, Shujiro Tsuji, Atsushi Sofuni, Takayoshi Tsuchiya, Reina Tanaka, Ryosuke Tonozuka, Yujiro Machida, Yoichi Takimoto, Hiroki Tamagawa, Tadashi Katayama, Shintaro Kawasaki, Takashi Seino, Masayasu Horibe, Seiichiro Fukuhara, Minoru Kitago, Haruhiko Ogata, Takanori Kanai

研究成果: Article

抄録

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).

元の言語English
ジャーナルDigestive Endoscopy
DOI
出版物ステータスAccepted/In press - 2019 1 1

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Randomized Controlled Trials
Hemorrhage
Pancreatitis
Adenoma
Artifacts
Registries
Incidence
Safety
Multicenter Studies
Neoplasms
Anatomy
Therapeutics
Clinical Trials

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

これを引用

Impact of electrical pulse cut mode during endoscopic papillectomy : Pilot randomized clinical trial. / Iwasaki, Eisuke; Minami, Kazuhiro; Itoi, Takao; Yamamoto, Kenjiro; Tsuji, Shujiro; Sofuni, Atsushi; Tsuchiya, Takayoshi; Tanaka, Reina; Tonozuka, Ryosuke; Machida, Yujiro; Takimoto, Yoichi; Tamagawa, Hiroki; Katayama, Tadashi; Kawasaki, Shintaro; Seino, Takashi; Horibe, Masayasu; Fukuhara, Seiichiro; Kitago, Minoru; Ogata, Haruhiko; Kanai, Takanori.

:: Digestive Endoscopy, 01.01.2019.

研究成果: Article

Iwasaki, E, Minami, K, Itoi, T, Yamamoto, K, Tsuji, S, Sofuni, A, Tsuchiya, T, Tanaka, R, Tonozuka, R, Machida, Y, Takimoto, Y, Tamagawa, H, Katayama, T, Kawasaki, S, Seino, T, Horibe, M, Fukuhara, S, Kitago, M, Ogata, H & Kanai, T 2019, 'Impact of electrical pulse cut mode during endoscopic papillectomy: Pilot randomized clinical trial', Digestive Endoscopy. https://doi.org/10.1111/den.13468
Iwasaki, Eisuke ; Minami, Kazuhiro ; Itoi, Takao ; Yamamoto, Kenjiro ; Tsuji, Shujiro ; Sofuni, Atsushi ; Tsuchiya, Takayoshi ; Tanaka, Reina ; Tonozuka, Ryosuke ; Machida, Yujiro ; Takimoto, Yoichi ; Tamagawa, Hiroki ; Katayama, Tadashi ; Kawasaki, Shintaro ; Seino, Takashi ; Horibe, Masayasu ; Fukuhara, Seiichiro ; Kitago, Minoru ; Ogata, Haruhiko ; Kanai, Takanori. / Impact of electrical pulse cut mode during endoscopic papillectomy : Pilot randomized clinical trial. :: Digestive Endoscopy. 2019.
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abstract = "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).",
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T1 - Impact of electrical pulse cut mode during endoscopic papillectomy

T2 - Pilot randomized clinical trial

AU - Iwasaki, Eisuke

AU - Minami, Kazuhiro

AU - Itoi, Takao

AU - Yamamoto, Kenjiro

AU - Tsuji, Shujiro

AU - Sofuni, Atsushi

AU - Tsuchiya, Takayoshi

AU - Tanaka, Reina

AU - Tonozuka, Ryosuke

AU - Machida, Yujiro

AU - Takimoto, Yoichi

AU - Tamagawa, Hiroki

AU - Katayama, Tadashi

AU - Kawasaki, Shintaro

AU - Seino, Takashi

AU - Horibe, Masayasu

AU - Fukuhara, Seiichiro

AU - Kitago, Minoru

AU - Ogata, Haruhiko

AU - Kanai, Takanori

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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).

AB - 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).

KW - adenoma

KW - common bile duct neoplasms

KW - electrosurgery

KW - pancreatitis

KW - pilot projects

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