6-mm vs 10-mm diameter fully covered self-expandable metal stents in patients with unresectable malignant distal bile duct stricture (COSMIC UNISON): study protocol for a multicenter, randomized controlled trial

被引：0

作者：

Yamada, Reiko ^{[1
]}

Tanaka, Takamitsu ^{[1
]}

Shimada, Yasuaki ^{[1
]}

Owa, Hirono ^{[1
]}

Nose, Kenji ^{[1
]}

Nakamura, Yoshifumi ^{[1
]}

Miwata, Tetsuro ^{[1
]}

Tsuboi, Junya ^{[1
]}

Hara, Kazuo ^{[2
]}

Hashigo, Shunpei ^{[3
]}

Hashimoto, Akira ^{[4
]}

Hijioka, Susumu ^{[5
]}

Okamoto, Kohei ^{[5
]}

Hirooka, Yoshiki ^{[6
]}

Imai, Hajime ^{[7
]}

Inoue, Tadahisa ^{[8
]}

Iwata, Keisuke ^{[9
]}

Kamada, Hideki ^{[10
]}

Kawaguchi, Shinya ^{[11
]}

Kawashima, Hiroki ^{[12
]}

Kobayashi, Yosuke ^{[13
]}

Maruta, Akinori ^{[14
]}

Mukai, Tsuyoshi ^{[15
]}

Murabayashi, Toji ^{[16
]}

Nakashima, Shigehito ^{[17
]}

Naota, Hiroaki ^{[18
]}

Okumura, Fumihiro ^{[19
]}

Oya, Yumi ^{[20
]}

Sato, Junya ^{[21
]}

Sugimoto, Ken ^{[22
]}

Hamaya, Yasushi ^{[22
]}

Tano, Shunsuke ^{[23
]}

Yoshinari, Motohiro ^{[24
]}

Imai, Yasuhito ^{[25
]}

Ogura, Toru ^{[25
]}

Tamaru, Satoshi ^{[25
]}

Nakagawa, Hayato ^{[1
]}

机构：

[1] Mie Univ Hosp, Dept Gastroenterol & Hepatol, 2-174 Edobashi, Tsu, Mie 5148507, Japan

[2] Aichi Canc Ctr Hosp, Dept Gastroenterol, Nagoya, Japan

[3] Kumamoto City Hosp, Dept Gastroenterol, Kumamoto, Japan

[4] Saiseikai Matsusaka Gen Hosp, Dept Internal Med, Matsusaka, Mie, Japan

[5] Natl Canc Ctr, Dept Hepatobiliary & Pancreat Oncol, Tokyo, Japan

[6] Fujita Hlth Univ, Dept Gastroenterol & Gastroenterol Oncol, Sch Med, Toyoake, Japan

[7] Okanami Gen Hosp, Dept Gastroenterol, Iga, Japan

[8] Aichi Med Univ, Dept Gastroenterol, Nagakute, Aichi, Japan

[9] Gifu Municipal Hosp, Dept Gastroenterol, Gifu, Japan

[10] Kagawa Univ, Dept Gastroenterol & Neurol, Takamatsu, Kagawa, Japan

[11] Shizuoka Prefectural Gen Hosp, Dept Gastroenterol, Shizuoka, Japan

[12] Nagoya Univ, Grad Sch Med, Grad Sch Med, Nagoya, Japan

[13] Seirei Hamamatsu Gen Hosp, Dept Gastroenterol, Hamamatsu, Japan

[14] Gifu Prefectural Gen Med Ctr, Dept Gastroenterol, Gifu, Japan

[15] Kanazawa Med Univ, Dept Gastroenterol Endoscopy, Uchinada, Ishikawa, Japan

[16] Ise Red Cross Hosp, Dept Gastroenterol, Ise, Mie, Japan

[17] Yokkaichi Hazu Med Ctr, Dept Surg, Yokaichi, Mie, Japan

[18] Matsusaka Chuo Gen Hosp, Dept Gastroenterol, Matsusaka, Mie, Japan

[19] Gifu Prefectural Tajimi Hosp, Dept Gastroenterol, Gifu, Japan

[20] Kuwana City Med Ctr, Dept Cardiol, Kuwana, Mie, Japan

[21] Shizuoka Canc Ctr, Div Endoscopy, Shizuoka, Japan

[22] Hamamatsu Univ, Sch Med, Dept Med 1, Hamamatsu, Japan

[23] Suzuka Kaisei Hosp, Dept Gastroenterol, Suzuka, Mie, Japan

[24] Kumamoto Univ, Dept Gastroenterol & Hepatol, Kumamoto, Japan

[25] Mie Univ Hosp, Clin Res Support Ctr, Tsu, Mie, Japan

来源：

TRIALS | 2025年 / 26卷 / 01期

关键词：

Endoscopic retrograde cholangiopancreatography; Malignant distal bile duct stricture; Recurrent biliary obstruction; Self-expandable metal stents; ENDOSCOPIC SNARE EXCISION; RISK-FACTORS; THERAPEUTIC ERCP; BILIARY; COMPLICATIONS; PANCREATITIS; CRITERIA;

D O I：

10.1186/s13063-025-08771-4

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BackgroundUnresectable malignant bile duct stricture (often caused by unresectable pancreatic cancer and cholangiocarcinoma) can be drained via insertion of self-expandable metal stents (SEMS) during endoscopic retrograde cholangiopancreatography (ERCP). Because recurrent biliary obstruction (RBO) and complications following stent insertion can delay chemotherapy and other treatments, a longer time to RBO (TRBO) is desirable. Although a longer TRBO has been reported among patients who undergo insertion with larger diameter SEMS, patients who undergo insertion with smaller diameter fully covered SEMS (FCSEMS) may have a lower incidence of complications than those with larger diameter FCSEMS. The aim of this study is to determine the TRBO and incidence of complications with 6-mm FCSEMS vs 10-mm FCSEMS in patients with unresectable malignant distal bile duct stricture.MethodsIn this multicenter, open-label, randomized controlled, non-inferiority trial (COSMIC UNISON), a target of 250 patients over 23 locations in Japan will receive either the 6-mm FCSEM or the standard 10-mm FCSEM during ERCP, with 125 patients in each group. The observation period will be 24 months, and patients will be enrolled from 15 March 2024 and assessed until the date of RBO or the study end (31 March 2029). The primary endpoint is TRBO, with RBO defined as the coexistence of abnormal liver enzyme values and dilation of the common bile duct and intrahepatic bile duct upstream of the stent. The secondary endpoints are the incidence and rates (at 3, 6, and 12 months) of non-RBO events, overall survival, cause of RBO, and symptomatic stent deviation. Adverse events from endoscopic procedures will be classified by the Lexicon Classification from the American Society of Endoscopy, and all other adverse events will be classified per the Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0.DiscussionThe COSMIC UNISON study is anticipated to provide evidence regarding the efficacy and safety of 6-mm vs 10-mm FCSEMS to inform the use of 6-mm FCSEMS for the treatment of unresectable malignant distal bile duct stricture.Trial registrationJapan Registry of Clinical Trials identifier: jRCT1042230170. Prospectively registered on 15 March 2024.

引用

页数：10

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