Clinical Research Directory
Browse clinical research sites, groups, and studies.
Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
Sponsor: Tokyo University
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.
Official title: Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2022-07-29
Completion Date
2031-04-11
Last Updated
2022-10-27
Healthy Volunteers
No
Conditions
Interventions
Immediate necrosectomy
Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the immediate necrosectomy group, endoscopic necrosectomy (EN) will be performed in the same session of EUS-guided drainage using a gastroscope. The endoscope is inserted into the WON cavity through the LAMS, and necrotic tissue is removed using biopsy forceps, snare, or basket catheter. The EN procedures will be repeated until clinical improvement.
Step-up approach
Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the step-up approach group, an additional interventional procedure will be withheld for 72-96 hours after initial EUS-guided drainage. In cases without clinical improvement after 72-96 hours, additional drainage will be permitted, which includes increasing the number of stents, additional EUS-guided drainage, and performing percutaneous drainage (step-up treatment). Insufficient improvement even after two times of step-up treatment allows subsequent endoscopic necrosectomy (EN).
Locations (21)
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, Kindai University Faculty of Medicine
Ōsaka-sayama, 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