Clinical Research Directory
Browse clinical research sites, groups, and studies.
Encapsulation-oriented vs. Timing-oriented Strategies for Necrotizing Pancreatitis
Sponsor: Tokyo University
Summary
This multicenter, randomized controlled trial (WONDER-03 study) investigates the optimal timing for endoscopic ultrasound (EUS)-guided drainage in patients with necrotizing pancreatitis. Although current guidelines recommend delaying drainage until at least four weeks after the onset of acute pancreatitis to allow for encapsulation of necrosis, recent observational data suggest that the degree of encapsulation itself may more strongly influence treatment success and safety. In this trial, patients are randomly assigned to one of two groups: an encapsulation-oriented group, in which EUS-guided drainage is performed when imaging confirms ≥80% encapsulation of the necrotic collection with symptoms, and a timing-oriented group, in which drainage is performed at four to five weeks after disease onset, regardless of encapsulation status. The primary endpoint is clinical success within 180 days, defined as both radiologic resolution of necrosis and improvement in symptoms. Secondary endpoints include adverse event rates, recurrence of fluid collections, technical and clinical success rates, and healthcare resource use. This study aims to determine whether a strategy based on encapsulation leads to better clinical outcomes than the conventional time-based approach and may help establish a new evidence-based treatment algorithm for necrotizing pancreatitis.
Official title: Encapsulation-oriented Versus Timing-oriented Strategies for the Timing of Endoscopic Ultrasound-guided Drainage in Necrotizing Pancreatitis After Acute Pancreatitis: A Multicenter Randomized Controlled Trial (WONDER-03)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2025-08-05
Completion Date
2028-07-31
Last Updated
2025-08-06
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (36)
Department of Gastroenterology, Aichi Medical University
Aichi, Japan, Japan
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Chiba, Japan, Japan
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
Fukuoka, Japan, Japan
Department of Gastroenterology, Gifu Municipal Hospital
Gifu, Japan, Japan
Department of Gastroenterology, Gifu Prefectural General Medical Center
Gifu, Japan, Japan
First Department of Internal Medicine, Gifu University Hospital
Gifu, Japan, Japan
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Hokkaido, Japan, Japan
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo MedicalUniversity
Hyōgo, Japan, Japan
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Kagawa, Japan, Japan
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
Kagoshima, Japan, Japan
Department of Gastroenterology, Kameda Medical Center
Kamogawa, Japan, Japan
Department of Gastroenterology, St. Marianna University School of Medicine
Kanagawa, Japan, Japan
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Kawagoe, Japan, Japan
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Kawasaki, Japan, Japan
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School ofMedicine
Kobe, Japan, Japan
Department of Gastroenterology and Hepatology, Mie University Hospital
Mie, Japan, Japan
Department of Gastroenterology and Hepatology, Okayama University Hospital
Okayama, Japan, Japan
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University
Osaka, Japan, Japan
Department of Gastroenterology and Hepatology, Kansai Medical University Medical Center
Osaka, Japan, Japan
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Osaka, Japan, Japan
Department of Gastroenterology, Shiga University of Medical Science
Shiga, Japan, Japan
Department of Gastroenterology, Tokyo Women's Medical University
Tokyo, Japan, Japan
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Tokyo, Japan, Japan
Department of Gastroenterology, Wakayama Medical University School of Medicine
Wakayama, Japan, Japan
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Aichi, Tokyo, Japan
Department of Gastroenterology, Nagoya University
Aichi, Tokyo, Japan
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, Fukuoka University
Fukuoka, Tokyo, Japan
Department of Gastroenterology, Kurume University
Fukuoka, Tokyo, Japan
Department of Gastroenterology, Matsunami General Hospital
Gifu, Tokyo, Japan
Department of Gastroenterology, Hiroshima University
Hiroshima, Tokyo, Japan
Department of Gastroenterology, JA Onomichi General Hospital
Hiroshima, Tokyo, Japan
Gastroenterology Center, Yokohama City University Medical Center
Kanagawa, Tokyo, Japan
Department of Gastrointestinal, Hepatobiliary and Pancreatic Diseases, Sendai City Medical Center (Sendai Open Hospital)
Miyagi, Tokyo, Japan
Third Department of Internal Medicine, University of Toyama
Toyama, Japan