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

Trials

Study Protocol

Tsuyoshi Mukai¹  Mamoru Takenaka²  Masaki Kuwatani³  Reiko Yamada⁴  Saburo Matsubara⁵  Hideki Kamada⁶  Tadahisa Inoue⁷  Keisuke Iwata⁸  Akinori Maruta⁹  Hiroshi Ohyama^1,10  Hiroyuki Isayama^1,11  Toshio Fujisawa^1,11  Tatsuya Sato^1,12  Tomotaka Saito^1,12  Yousuke Nakai^1,13  Tsuyoshi Hamada^1,14  Toshiyasu Shiratori^1,15  Kazunari Nakahara^1,16  Shinpei Doi^1,17  Kenji Chinen^1,18  Shinichi Hashimoto^1,19  Hideyuki Shiomi^2,20  Hirofumi Kogure^2,21  Atsuhiro Masuda^2,22  Takeshi Ogura^2,23  Takuji Iwashita^2,24  Ichiro Yasuda^2,25  Nobuhiko Hayashi^2,25 

[1] Department of Gastroenterological Endoscopy, Kanazawa Medical University, Ishikawa, Japan;Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan;Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido, Japan;Department of Gastroenterology and Hepatology, Mie University Hospital, Mie, Japan;Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan;Department of Gastroenterology and Neurology, Kagawa University, Kagawa, Japan;Department of Gastroenterology, Aichi Medical University, Aichi, Japan;Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan;Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, Japan;Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan;Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan;Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital, Tokyo, Japan;Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;Department of Hepato-Biliary-Pancreatic Medicine, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan;Department of Gastroenterology, Kameda Medical Center, Chiba, Japan;Department of Gastroenterology, St. Marianna University School of Medicine, Kanagawa, Japan;Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan;Department of Gastroenterology, Yuuai Medical Center, Okinawa, Japan;Digestive and Life-Style Diseases, Kagoshima University Graduate School of Medicine and Dental Sciences, Kagoshima, Japan;Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, Hyogo, Japan;Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan;Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan;Endoscopy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan;First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan;Third Department of Internal Medicine, University of Toyama, Toyama, Japan;

关键词: Acute necrotizing pancreatitis;    Drainage;    Endoscopy;    Endosonography;    Randomised clinical trial;    Stents;    Ultrasonography;    Walled-off necrosis;   

DOI  :  10.1186/s13063-023-07377-y

 received in 2022-12-15, accepted in 2023-05-15,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundWith 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.MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.gov NCT05451901, registered on 11 July 2022. UMIN000048310, registered on 7 July 2022. jRCT1032220055, registered on 1 May 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

41116_2023_36_Article_IEq239.gif