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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2024年8月24日

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  • Tomotaka Saito,
  • Mamoru Takenaka,
  • Masaki Kuwatani,
  • Shinpei Doi,
  • Hiroshi Ohyama,
  • Toshio Fujisawa,
  • Atsuhiro Masuda,
  • Takuji Iwashita,
  • Hideyuki Shiomi,
  • Nobuhiko Hayashi,
  • Keisuke Iwata,
  • Akinori Maruta,
  • Tsuyoshi Mukai,
  • Saburo Matsubara,
  • Tsuyoshi Hamada,
  • Tadahisa Inoue,
  • Kazuyuki Matsumoto,
  • Sumio Hirose,
  • Nao Fujimori,
  • Kosuke Kashiwabara,
  • Hideki Kamada,
  • Shinichi Hashimoto,
  • Toshiyasu Shiratori,
  • Reiko Yamada,
  • Hirofumi Kogure,
  • Kazunari Nakahara,
  • Takeshi Ogura,
  • Masayuki Kitano,
  • Ichiro Yasuda,
  • Hiroyuki Isayama,
  • Yousuke Nakai,
  • Shunsuke Omoto,
  • Shinya Uemura,
  • Ryota Nakano,
  • Yuta Kawase,
  • Sho Takahashi,
  • Mitsuru Okuno,
  • Yuhei Iwasa,
  • Kensaku Yoshida,
  • Shogo Ota,
  • Masahiro Tsujimae,
  • Arata Sakai,
  • Kentaro Suda,
  • Naminatsu Takahara,
  • Kazunaga Ishigaki,
  • Ryunosuke Hakuta,
  • Tatsuya Sato,
  • Rena Kitano,
  • Motoyasu Kan,
  • Hiroki Nagashima,
  • Yotaro Iino,
  • Koji Takahashi,
  • Kazumichi Kawakubo,
  • Ryo Sugiura,
  • Kazuma Kishi,
  • Hiroki Yonemura,
  • Shunichiro Nozawa,
  • Ryota Nakabayashi,
  • Namima Daisuke,
  • Makoto Hinokuchi,
  • So Nakaji,
  • Kenji Nose,
  • Kei Saito,
  • Shuzo Nomura,
  • Mariko Fujisawa,
  • Nobuyuki Kuniyoshi,
  • Atsushi Okuda,
  • Saori Ueno,
  • Akira Miyano,
  • Nobu Nishioka,
  • Yusuke Satta,
  • Nobuhiro Katsukura,
  • Masahiro Itonaga,
  • Reiko Ashida,
  • Takashi Tamura,
  • Takahiro Shishimoto,
  • Yuki Kawaji,
  • Hironari Kato,
  • Ryosuke Sato,
  • Keijiro Ueda,
  • Katsuhito Teramatsu,
  • Kazuhide Matsumoto

摘要

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.