학술논문
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
Document Type
Original Paper
Author
Sato, Tatsuya; Saito, Tomotaka; Takenaka, Mamoru; Iwashita, Takuji; Shiomi, Hideyuki; Fujisawa, Toshio; Hayashi, Nobuhiko; Iwata, Keisuke; Maruta, Akinori; Mukai, Tsuyoshi; Masuda, Atsuhiro; Matsubara, Saburo; Hamada, Tsuyoshi; Inoue, Tadahisa; Ohyama, Hiroshi; Kuwatani, Masaki; Kamada, Hideki; Hashimoto, Shinichi; Shiratori, Toshiyasu; Yamada, Reiko; Kogure, Hirofumi; Ogura, Takeshi; Nakahara, Kazunari; Doi, Shinpei; Chinen, Kenji; Isayama, Hiroyuki; Yasuda, Ichiro; Nakai, Yousuke
Source
Trials. 24(1)
Subject
Language
English
ISSN
1745-6215
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.