Abstract

Background

Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.

Methods

The WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator’s discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs.

Discussion

The WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population.

Trial registration

ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.

Details

Title
WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts—study protocol for a multicentre randomised non-inferiority trial
Author
Saito, Tomotaka 1   VIAFID ORCID Logo  ; Takenaka, Mamoru 2 ; Kuwatani, Masaki 3 ; Doi, Shinpei 4 ; Ohyama, Hiroshi 5 ; Fujisawa, Toshio 6 ; Masuda, Atsuhiro 7 ; Iwashita, Takuji 8 ; Shiomi, Hideyuki 9 ; Hayashi, Nobuhiko 10 ; Iwata, Keisuke 11 ; Maruta, Akinori 12 ; Mukai, Tsuyoshi 13 ; Matsubara, Saburo 14 ; Hamada, Tsuyoshi 15 ; Inoue, Tadahisa 16 ; Matsumoto, Kazuyuki 17 ; Hirose, Sumio 18 ; Fujimori, Nao 19 ; Kashiwabara, Kosuke 20 ; Kamada, Hideki 21 ; Hashimoto, Shinichi 22 ; Shiratori, Toshiyasu 23 ; Yamada, Reiko 24 ; Kogure, Hirofumi 25 ; Nakahara, Kazunari 26 ; Ogura, Takeshi 27 ; Kitano, Masayuki 28 ; Yasuda, Ichiro 10 ; Isayama, Hiroyuki 6 ; Nakai, Yousuke 29   VIAFID ORCID Logo  ; Omoto, Shunsuke; Uemura, Shinya; Nakano, Ryota; Kawase, Yuta; Takahashi, Sho; Okuno, Mitsuru; Iwasa, Yuhei; Yoshida, Kensaku; Ota, Shogo; Tsujimae, Masahiro; Sakai, Arata; Suda, Kentaro; Takahara, Naminatsu; Ishigaki, Kazunaga; Hakuta, Ryunosuke; Sato, Tatsuya; Kitano, Rena; Kan, Motoyasu; Nagashima, Hiroki; Iino, Yotaro; Takahashi, Koji; Kawakubo, Kazumichi; Sugiura, Ryo; Kishi, Kazuma; Yonemura, Hiroki; Nozawa, Shunichiro; Nakabayashi, Ryota; Daisuke, Namima; Hinokuchi, Makoto; Nakaji, So; Nose, Kenji; Saito, Kei; Nomura, Shuzo; Fujisawa, Mariko; Kuniyoshi, Nobuyuki; Okuda, Atsushi; Ueno, Saori; Miyano, Akira; Nishioka, Nobu; Satta, Yusuke; Katsukura, Nobuhiro; Itonaga, Masahiro; Ashida, Reiko; Tamura, Takashi; Shishimoto, Takahiro; Kawaji, Yuki; Kato, Hironari; Sato, Ryosuke; Ueda, Keijiro; Teramatsu, Katsuhito; Matsumoto, Kazuhide

1  The University of Tokyo, Department of Gastroenterology, Graduate School of Medicine, Tokyo, Japan (GRID:grid.26999.3d) (ISNI:0000 0001 2169 1048) 
2  Kindai University, Department of Gastroenterology and Hepatology, Faculty of Medicine, Osaka, Japan (GRID:grid.258622.9) (ISNI:0000 0004 1936 9967) 
3  Hokkaido University Hospital, Department of Gastroenterology and Hepatology, Hokkaido, Japan (GRID:grid.412167.7) (ISNI:0000 0004 0378 6088) 
4  Teikyo University Mizonokuchi Hospital, Department of Gastroenterology, Kanagawa, Japan (GRID:grid.264706.1) (ISNI:0000 0000 9239 9995) 
5  Chiba University, Department of Gastroenterology, Graduate School of Medicine, Chiba, Japan (GRID:grid.136304.3) (ISNI:0000 0004 0370 1101) 
6  Juntendo University, Department of Gastroenterology, Graduate School of Medicine, Tokyo, Japan (GRID:grid.258269.2) (ISNI:0000 0004 1762 2738) 
7  Kobe University Graduate School of Medicine, Division of Gastroenterology, Department of Internal Medicine, Hyogo, Japan (GRID:grid.31432.37) (ISNI:0000 0001 1092 3077) 
8  Gifu University Hospital, First Department of Internal Medicine, Gifu, Japan (GRID:grid.411704.7) 
9  Hyogo Medical University, Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo, Japan (GRID:grid.272264.7) (ISNI:0000 0000 9142 153X) 
10  University of Toyama, Third Department of Internal Medicine, Toyama, Japan (GRID:grid.267346.2) (ISNI:0000 0001 2171 836X) 
11  Gifu Municipal Hospital, Department of Gastroenterology, Gifu, Japan (GRID:grid.415535.3) 
12  Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, Japan (GRID:grid.415536.0) 
13  Kanazawa Medical University, Department of Gastroenterological Endoscopy, Ishikawa, Japan (GRID:grid.411998.c) (ISNI:0000 0001 0265 5359) 
14  Saitama Medical Center, Saitama Medical University, Department of Gastroenterology and Hepatology, Saitama, Japan (GRID:grid.416093.9) 
15  The University of Tokyo, Department of Gastroenterology, Graduate School of Medicine, Tokyo, Japan (GRID:grid.26999.3d) (ISNI:0000 0001 2169 1048); Cancer Institute Hospital, Japanese Foundation for Cancer Research, Department of Hepato-Biliary-Pancreatic Medicine, Tokyo, Japan (GRID:grid.410807.a) (ISNI:0000 0001 0037 4131) 
16  Aichi Medical University, Department of Gastroenterology, Aichi, Japan (GRID:grid.411234.1) (ISNI:0000 0001 0727 1557) 
17  Okayama University Hospital, Department of Gastroenterology and Hepatology, Okayama, Japan (GRID:grid.412342.2) (ISNI:0000 0004 0631 9477) 
18  Yamanashi Prefectural Central Hospital, Department of Gastroenterology, Yamanashi, Japan (GRID:grid.417333.1) (ISNI:0000 0004 0377 4044) 
19  Kyushu University, Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Fukuoka, Japan (GRID:grid.177174.3) (ISNI:0000 0001 2242 4849) 
20  The University of Tokyo Hospital, Data Science Office, Clinical Research Promotion Center, Tokyo, Japan (GRID:grid.412708.8) (ISNI:0000 0004 1764 7572) 
21  Kagawa University, Department of Gastroenterology and Neurology, Kagawa, Japan (GRID:grid.258331.e) (ISNI:0000 0000 8662 309X) 
22  Kagoshima University Graduate School of Medicine and Dental Sciences, Digestive and Life-Style Diseases, Kagoshima, Japan (GRID:grid.258333.c) (ISNI:0000 0001 1167 1801) 
23  Kameda Medical Center, Department of Gastroenterology, Chiba, Japan (GRID:grid.414927.d) (ISNI:0000 0004 0378 2140) 
24  Mie University Hospital, Department of Gastroenterology and Hepatology, Mie, Japan (GRID:grid.412075.5) (ISNI:0000 0004 1769 2015) 
25  Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, Tokyo, Japan (GRID:grid.260969.2) (ISNI:0000 0001 2149 8846) 
26  St. Marianna University School of Medicine, Department of Gastroenterology, Kanagawa, Japan (GRID:grid.412764.2) (ISNI:0000 0004 0372 3116) 
27  Osaka Medical and Pharmaceutical University Hospital, Endoscopy Center, Osaka, Japan (GRID:grid.444883.7) (ISNI:0000 0001 2109 9431) 
28  Wakayama Medical University School of Medicine, Department of Gastroenterology, Wakayama, Japan (GRID:grid.412857.d) (ISNI:0000 0004 1763 1087) 
29  The University of Tokyo, Department of Gastroenterology, Graduate School of Medicine, Tokyo, Japan (GRID:grid.26999.3d) (ISNI:0000 0001 2169 1048); The University of Tokyo Hospital, Department of Endoscopy and Endoscopic Surgery, Tokyo, Japan (GRID:grid.412708.8) (ISNI:0000 0004 1764 7572) 
Pages
559
Publication year
2024
Publication date
Dec 2024
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-024-08373-6
ProQuest document ID
3096585737
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.