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

• Published in: Trials 2023, Vol.24 (1)
• Main Authors: 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
• Format: Report
• Language: English
• Subjects: Analysis; Blood cell count; Care and treatment; Complications and side effects; Diagnosis; Drainage, Surgical; Endoscopic ultrasonography; Forecasts and trends; Health aspects; Japan; Mortality; Necrosis; Pancreatitis; Patient outcomes; Prevention
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07377-y

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 [greater than or equal to] 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 [less than or equai 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. Keywords: Acute necrotizing pancreatitis, Drainage, Endoscopy, Endosonography, Randomised clinical trial, Stents, Ultrasonography, Walled-off necrosis