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
Affiliations
Tatsuya Sato
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Tomotaka Saito
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Mamoru Takenaka
Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University
Takuji Iwashita
First Department of Internal Medicine, Gifu University Hospital
Hideyuki Shiomi
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University
Toshio Fujisawa
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Nobuhiko Hayashi
Third Department of Internal Medicine, University of Toyama
Keisuke Iwata
Department of Gastroenterology, Gifu Municipal Hospital
Akinori Maruta
Department of Gastroenterology, Gifu Prefectural General Medical Center
Tsuyoshi Mukai
Department of Gastroenterological Endoscopy, Kanazawa Medical University
Atsuhiro Masuda
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Saburo Matsubara
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Tsuyoshi Hamada
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Tadahisa Inoue
Department of Gastroenterology, Aichi Medical University
Hiroshi Ohyama
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Masaki Kuwatani
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Hideki Kamada
Department of Gastroenterology and Neurology, Kagawa University
Shinichi Hashimoto
Digestive and Life-Style Diseases, Kagoshima University Graduate School of Medicine and Dental Sciences
Toshiyasu Shiratori
Department of Gastroenterology, Kameda Medical Center
Reiko Yamada
Department of Gastroenterology and Hepatology, Mie University Hospital
Hirofumi Kogure
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Takeshi Ogura
Endoscopy Center, Osaka Medical and Pharmaceutical University Hospital
Kazunari Nakahara
Department of Gastroenterology, St. Marianna University School of Medicine
Shinpei Doi
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Kenji Chinen
Department of Gastroenterology, Yuuai Medical Center
Hiroyuki Isayama
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Ichiro Yasuda
Third Department of Internal Medicine, University of Toyama
Yousuke Nakai
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
for the WONDERFUL study group in Japan, collaborators
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.
