70
Participants
Start Date
July 29, 2022
Primary Completion Date
April 1, 2025
Study Completion Date
April 11, 2031
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)."
NOT_YET_RECRUITING
Department of Gastroenterology, The University of Tokyo Hospital, Bunkyō-Ku
RECRUITING
Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Bunkyō-Ku
RECRUITING
Department of Gastroenterology, Aichi Medical University, Aichi
RECRUITING
Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba
RECRUITING
Department of Gastroenterology, Gifu Municipal Hospital, Gifu
RECRUITING
Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu
NOT_YET_RECRUITING
First Department of Internal Medicine, Gifu University Hospital, Gifu
RECRUITING
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, Hyōgo
RECRUITING
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Kagawa
RECRUITING
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima
RECRUITING
Department of Gastroenterology, Kameda Medical Center, Kamogawa
NOT_YET_RECRUITING
Department of Gastroenterological Endoscopy, Kanazawa Medical University, Kanazawa
NOT_YET_RECRUITING
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Kawagoe
NOT_YET_RECRUITING
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki
RECRUITING
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe
RECRUITING
Department of Gastroenterology, Yuuai Medical Center, Okinawa
NOT_YET_RECRUITING
2nd Department of Internal Medicine, Osaka Medical College, Osaka
NOT_YET_RECRUITING
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Ōsaka-sayama
RECRUITING
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo
NOT_YET_RECRUITING
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo
RECRUITING
Third Department of Internal Medicine, University of Toyama, Toyama
Tokyo University
OTHER