ID | 63994 |
フルテキストURL | |
著者 |
Matsumoto, Kazuyuki
Department of Gastroenterology and Hepatology, Okayama University Hospital
ORCID
Kaken ID
publons
Mitsuhashi, Toshiharu
Center for Innovative Clinical Medicine, Okayama University Hospital
Kaken ID
researchmap
Kawamoto, Hirofumi
Department of General Internal Medicine 2, Kawasaki Medical School
Ishida, Etsuji
Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
Fujii, Masakuni
Department of Internal Medicine, Okayama Saiseikai General Hospital
Akimoto, Yutaka
Department of Gastroenterology, Japanese Red Cross Okayama Hospital
Seki, Hiroyuki
Department of Gastroenterology, Mitoyo General Hospital
Ishihara, Yuki
Department of Gastroenterology, Iwakuni Medical Center
Ogawa, Taiji
Department of Gastroenterology, Tsuyama Central Hospital
Yamazaki, Tatsuhiro
Department of Gastroenterology and Hepatology, Okayama University Hospital
Fujii, Yuki
Department of Gastroenterology and Hepatology, Okayama University Hospital
Kato, Hironari
Department of Gastroenterology and Hepatology, Okayama University Hospital
ORCID
Kaken ID
researchmap
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抄録 | Introduction: Bilateral endoscopic drainage with self-expanding metallic stent (SEMS) can be used to manage hilar malignant biliary obstruction (HMBO) more effectively in comparison to unilateral drainage. An increased drainage area is predicted to prolong stent patency and patient survival. However, few reports have described the utility of trisegmental drainage and the benefits of using trisegmental drainage remain unknown. Thus, we launched a randomized clinical trial (RCT) to compare the clinical outcomes between bilateral and trisegmental drainage using SEMSs in patients with high-grade HMBO. Methods and analysis: This study was conducted as a multicenter randomized control trial (RCT) in 8 high-volume medical centers in Japan, and will prove the non-inferiority of bilateral drainage to trisegmental drainage. Patients with unresectable HMBO with Bismuth type IIIa or IV who pass the inclusion and exclusion criteria will be randomized to receive bilateral or trisegmental drainage at a 1:1 ratio. At each center, the on-site study investigators will obtain informed consent from the candidates, and will use an electronic data capture system (REDCap) to input necessary information, and register candidates with the registration secretariat. The primary endpoint is the rate of non-recurrent biliary obstruction (RBO) at 180 days after SEMSs placement. A -10% non-inferiority margin is assumed in the statistical analysis of the primary endpoint. Secondary endpoints include the rate of technical and clinical success, time to recurrent biliary obstruction (TRBO), causes of RBO, procedure-related adverse events (AEs), procedure time, TRBO with or without endoscopic sphincterotomy, overall survival, and the technical and clinical success rates at reintervention. Discussion: If the non-inferiority of bilateral drainage is demonstrated, it is predicted that the procedure time will be shortened and the medical cost will be reduced, which will be beneficial to the patient and the medical economy.
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キーワード | bilateral drainage
bile duct obstruction
endoscopic biliary drainage
neoplasms
self-expandable metallic stents
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発行日 | 2022-10-07
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出版物タイトル |
Medicine
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巻 | 101巻
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号 | 40号
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出版者 | Lippincott Williams & Wilkins
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開始ページ | e30857
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ISSN | 0025-7974
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資料タイプ |
学術雑誌論文
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言語 |
英語
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OAI-PMH Set |
岡山大学
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著作権者 | © 2022 the Author(s).
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論文のバージョン | publisher
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PubMed ID | |
DOI | |
Web of Science KeyUT | |
関連URL | isVersionOf https://doi.org/10.1097/MD.0000000000030857
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ライセンス | https://creativecommons.org/licenses/by/4.0/
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