224
Participants
Start Date
August 5, 2025
Primary Completion Date
July 31, 2028
Study Completion Date
July 31, 2028
The timing of endoscopic intervention for necrotizing pancreatitis is determined based on the degree of encapsulation
In the encapsulation-oriented group, participants undergo EUS-guided drainage of necrotizing pancreatitis when the degree of encapsulation reaches ≥80%, as confirmed by cross-sectional imaging (preferably contrast-enhanced CT). Imaging is repeated every 7-10 days after enrollment to assess encapsulation. Once sufficient encapsulation is observed and the patient presents with symptoms such as infection, abdominal pain, GOO or biliary obstruction, endoscopic drainage is performed. Drainage is typically performed using a lumen-apposing metal stent (LAMS) placed under EUS guidance, often accompanied by placement of an external drain. Step-up therapy, including endoscopic necrosectomy or additional drainage procedures, may be used if symptoms do not improve. If the patient improves with conservative therapy before encapsulation is achieved, drainage may be deferred. Endoscopic/percutaneous interventions should, in principle, be discussed with the expert panel beforehand.
EUS-guided drainage based on the interval from the onset of acute pancreatitis
In the timing-oriented group, participants undergo EUS-guided drainage of necrotizing pancreatitis at 4 to 5 weeks after the onset of acute pancreatitis, regardless of the degree of encapsulation. Drainage is performed only in symptomatic patients who meet predefined clinical criteria, such as signs of infection, significant pain, GOO, or biliary obstruction. Imaging is performed before the procedure. The standard approach involves placing a LAMS under EUS guidance, optionally supplemented by external drains. If symptoms do not improve, step-up interventions such as endoscopic necrosectomy, percutaneous drainage may be considered. If inflammation and symptoms improve with conservative treatment (e.g., antibiotics), EUS-guided drainage may be omitted. Conversely, even before 4-5 weeks from onset, early drainage is allowed if conservative treatment is deemed insufficient by the attending physician. In principle, intervention decisions should be discussed with the expert panel.
Department of Gastroenterology, Aichi Medical University, Aichi
Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka
Department of Gastroenterology, Gifu Municipal Hospital, Gifu
Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu
First Department of Internal Medicine, Gifu University Hospital, Gifu
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo MedicalUniversity, Hyōgo
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Kagawa
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima
Department of Gastroenterology, Kameda Medical Center, Kamogawa
Department of Gastroenterology, St. Marianna University School of Medicine, Kanagawa
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Kawagoe
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School ofMedicine, Kobe
Department of Gastroenterology and Hepatology, Mie University Hospital, Mie
Department of Gastroenterology and Hepatology, Okayama University Hospital, Okayama
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka
Department of Gastroenterology and Hepatology, Kansai Medical University Medical Center, Osaka
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka
Department of Gastroenterology, Shiga University of Medical Science, Shiga
Department of Gastroenterology, Tokyo Women's Medical University, Tokyo
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo
Department of Gastroenterology, Wakayama Medical University School of Medicine, Wakayama
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Aichi
Department of Gastroenterology, Nagoya University, Aichi
Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Bunkyō-Ku
Department of Gastroenterology, Fukuoka University, Fukuoka
Department of Gastroenterology, Kurume University, Fukuoka
Department of Gastroenterology, Matsunami General Hospital, Gifu
Department of Gastroenterology, Hiroshima University, Hiroshima
Department of Gastroenterology, JA Onomichi General Hospital, Hiroshima
Gastroenterology Center, Yokohama City University Medical Center, Kanagawa
Department of Gastrointestinal, Hepatobiliary and Pancreatic Diseases, Sendai City Medical Center (Sendai Open Hospital), Miyagi
Third Department of Internal Medicine, University of Toyama, Toyama
Department of Gastroenterology, The University of Tokyo Hospital, Bunkyō-Ku
Tokyo Women's Medical University
OTHER
Tokyo University
OTHER