Spots Global Cancer Trial Database for Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
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Trial Identification
Brief Title: Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
Official Title: Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)
Study ID: NCT05451901
Study Description
Brief Summary: Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
Detailed Description: Pancreatic fluid collection is a late complication of severe acute pancreatitis. According to the revised Atlanta classification, walled-off necrosis (WON) is defined as an encapsulated collection of necrotic tissue that is observed after four weeks of the onset of acute pancreatitis. Infected WON is associated with high morbidity and mortality; therefore, an appropriate treatment, including antibiotics and drainage, is mandatory. With the development of endoscopic equipment, endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality for infected WON. For patients who are refractory to EUS-guided drainage, endoscopic necrosectomy (EN) is a treatment option to facilitate direct removal of infected necrotic tissue within the WON. However, due to potentially lethal adverse events of EN, such as bleeding, perforation, and peritonitis, EN is usually withheld for several days after EUS-guided drainage. This strategy is known as "the step-up approach." Recently, with the accumulated evidence supporting the safety of EN, especially with the use of a dedicated lumen-apposing metal stent, it has been reported that EN immediately after EUS-guided drainage can shorten the treatment duration without increasing adverse events. Given these lines of evidence, the investigators hypothesized that immediate EN following EUS-guided drainage of WON might shorten time to clinical success compared to the step-up approach. To examine this hypothesis, the investigators planned to conduct a multicenter randomized controlled trial comparing treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Gastroenterology, The University of Tokyo Hospital, Bunkyō-Ku, Tokyo, Japan
Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Bunkyō-Ku, Tokyo, Japan
Department of Gastroenterology, Aichi Medical University, Aichi, , Japan
Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, , Japan
Department of Gastroenterology, Gifu Municipal Hospital, Gifu, , Japan
Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, , Japan
First Department of Internal Medicine, Gifu University Hospital, Gifu, , Japan
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, Hyōgo, , Japan
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Kagawa, , Japan
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, , Japan
Department of Gastroenterology, Kameda Medical Center, Kamogawa, , Japan
Department of Gastroenterological Endoscopy, Kanazawa Medical University, Kanazawa, , Japan
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Kawagoe, , Japan
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, , Japan
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, , Japan
Department of Gastroenterology, Yuuai Medical Center, Okinawa, , Japan
2nd Department of Internal Medicine, Osaka Medical College, Osaka, , Japan
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, , Japan
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, , Japan
Third Department of Internal Medicine, University of Toyama, Toyama, , Japan
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Ōsaka-sayama, , Japan
Contact Details
Name: Yousuke Nakai
Affiliation: Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo
Role: PRINCIPAL_INVESTIGATOR
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