Trials (May 2023)

WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis—study protocol for a multicentre randomised controlled trial

  • Tatsuya Sato,
  • Tomotaka Saito,
  • Mamoru Takenaka,
  • Takuji Iwashita,
  • Hideyuki Shiomi,
  • Toshio Fujisawa,
  • Nobuhiko Hayashi,
  • Keisuke Iwata,
  • Akinori Maruta,
  • Tsuyoshi Mukai,
  • Atsuhiro Masuda,
  • Saburo Matsubara,
  • Tsuyoshi Hamada,
  • Tadahisa Inoue,
  • Hiroshi Ohyama,
  • Masaki Kuwatani,
  • Hideki Kamada,
  • Shinichi Hashimoto,
  • Toshiyasu Shiratori,
  • Reiko Yamada,
  • Hirofumi Kogure,
  • Takeshi Ogura,
  • Kazunari Nakahara,
  • Shinpei Doi,
  • Kenji Chinen,
  • Hiroyuki Isayama,
  • Ichiro Yasuda,
  • Yousuke Nakai,
  • for the WONDERFUL study group in Japan, collaborators

DOI
https://doi.org/10.1186/s13063-023-07377-y
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 12

Abstract

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Abstract Background With the increasing popularity of endoscopic ultrasound (EUS)-guided transmural interventions, walled-off necrosis (WON) of the pancreas is increasingly managed via non-surgical endoscopic interventions. However, there has been an ongoing debate over the appropriate treatment strategy following the initial EUS-guided drainage. Direct endoscopic necrosectomy (DEN) removes intracavity necrotic tissue, potentially facilitating early resolution of the WON, but may associate with a high rate of adverse events. Given the increasing safety of DEN, we hypothesised that immediate DEN following EUS-guided drainage of WON might shorten the time to WON resolution compared to the drainage-oriented step-up approach. Methods The WONDER-01 trial is a multicentre, open-label, superiority, randomised controlled trial, which will enrol WON patients aged ≥ 18 years requiring EUS-guided treatment in 23 centres in Japan. This trial plans to enrol 70 patients who will be randomised at a 1:1 ratio to receive either the immediate DEN or drainage-oriented step-up approach (35 patients per arm). In the immediate DEN group, DEN will be initiated during (or within 72 h of) the EUS-guided drainage session. In the step-up approach group, drainage-based step-up treatment with on-demand DEN will be considered after 72–96 h observation. The primary endpoint is time to clinical success, which is defined as a decrease in a WON size to ≤ 3 cm and an improvement of inflammatory markers (i.e. body temperature, white blood cell count, and C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, and recurrence of the WON. Discussion The WONDER-01 trial will investigate the efficacy and safety of immediate DEN compared to the step-up approach for WON patients receiving EUS-guided treatment. The findings will help us to establish new treatment standards for patients with symptomatic WON. Trial registration ClinicalTrials.gov NCT05451901, registered on 11 July 2022. UMIN000048310, registered on 7 July 2022. jRCT1032220055, registered on 1 May 2022.

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