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. 2024 Aug 24;25(1):559.
doi: 10.1186/s13063-024-08373-6.

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

Tomotaka Saito #  1 , Mamoru Takenaka #  2 , Masaki Kuwatani #  3 , Shinpei Doi  4 , Hiroshi Ohyama  5 , Toshio Fujisawa  6 , Atsuhiro Masuda  7 , Takuji Iwashita  8 , Hideyuki Shiomi  9 , Nobuhiko Hayashi  10 , Keisuke Iwata  11 , Akinori Maruta  12 , Tsuyoshi Mukai  13 , Saburo Matsubara  14 , Tsuyoshi Hamada  1   15 , Tadahisa Inoue  16 , Kazuyuki Matsumoto  17 , Sumio Hirose  18 , Nao Fujimori  19 , Kosuke Kashiwabara  20 , Hideki Kamada  21 , Shinichi Hashimoto  22 , Toshiyasu Shiratori  23 , Reiko Yamada  24 , Hirofumi Kogure  25 , Kazunari Nakahara  26 , Takeshi Ogura  27 , Masayuki Kitano  28 , Ichiro Yasuda #  10 , Hiroyuki Isayama #  6 , Yousuke Nakai #  29   30 ; WONDERFUL study group in Japan and collaborators
Collaborators, Affiliations

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

Tomotaka Saito et al. Trials. .

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.

Keywords: Drainage; Endoscopy; Endosonography; Mortality; Pancreatic fistula; Pancreatic pseudocyst; Pancreatitis; Randomised clinical trial; Sepsis; Stents.

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Conflict of interest statement

H.I. declares research funding from Boston Scientific Japan, Fujifilm, and Piolax Medical Devices; honoraria from Boston Scientific Japan, Century Medical, Create Medic, Fujifilm, Gadelius Medical, Hitachi Medical, Japan Lifeline, Kaneka, Kawasumi Laboratories, Olympus Medical, Piolax Medical Devices, Sumitomo Bakelite, UMIDAS, and Zeon Medical; and contributions from Boston Scientific Japan, Gadelius Medical, Japan Lifeline, and Zeon Medical. Y.N. declares research funding from Boston Scientific Japan, Century Medical, Fujifilm, Gadelius Medical, HOYA Pentax Medical, Hitachi Medical, Kaneka, and Medico’s Hirata; and honoraria from Boston Scientific Japan, Fujifilm, Gadelius Medical, Hitachi Medical, J-MIT, Medico’s Hirata, and Olympus Medical. This work was not supported by any of those companies. The other authors declare no conflicts of interest related to this article.

Figures

Fig. 1
Fig. 1
Flow diagram summarising the experimental and control interventions that are examined in the WONDER-02 trial. Abbreviations: EUS, endoscopic ultrasound; LAMS, lumen-apposing metal stent
See this image and copyright information in PMC

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