Trials (Aug 2024)

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,
  • 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,
  • for the WONDERFUL study group in Japan and collaborators

DOI
https://doi.org/10.1186/s13063-024-08373-6
Journal volume & issue
Vol. 25, no. 1
pp. 1 – 14

Abstract

Read online

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