Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis (WONDER-01)
Pancreatic Fluid Collection, Walled-off Necrosis, Pancreatitis, Acute Necrotizing
About this trial
This is an interventional treatment trial for Pancreatic Fluid Collection focused on measuring Endosonography, Drainage, Stents, Endoscopic necrosectomy, Step-up approach
Eligibility Criteria
Inclusion Criteria:
- Patients with WON defined according to the revised Atlanta classification
- The longest diameter of WON is 4 cm or larger
- Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice
- Patients who need drainage for WON
- Age of 18 years or older
- Patients or their representatives provide informed consent
- Patients who visit or are hospitalized at the participating institutions
Exclusion Criteria:
- WON inaccessible by EUS-guided approach
- AXIOS stent has already been placed into the WON prior to the enrollment
- Severe coagulopathy; Platelet count < 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) >1.5
- Patients on antithrombotic agents which cannot be managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)"
- Patients who cannot tolerate endoscopic procedures
- Pregnant women
- Patients considered inappropriate for inclusion by investigators
Sites / Locations
- Department of Gastroenterology, The University of Tokyo Hospital
- Department of Gastroenterology, Graduate School of Medicine, Juntendo UniversityRecruiting
- Department of Gastroenterology, Aichi Medical UniversityRecruiting
- Department of Gastroenterology, Graduate School of Medicine, Chiba UniversityRecruiting
- Department of Gastroenterology, Gifu Municipal HospitalRecruiting
- Department of Gastroenterology, Gifu Prefectural General Medical CenterRecruiting
- First Department of Internal Medicine, Gifu University Hospital
- Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical UniversityRecruiting
- Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa UniversityRecruiting
- Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental SciencesRecruiting
- Department of Gastroenterology, Kameda Medical CenterRecruiting
- Department of Gastroenterological Endoscopy, Kanazawa Medical University
- Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
- Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of MedicineRecruiting
- Department of Gastroenterology, Yuuai Medical CenterRecruiting
- 2nd Department of Internal Medicine, Osaka Medical College
- Department of Gastroenterology and Hepatology, Hokkaido University HospitalRecruiting
- Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
- Third Department of Internal Medicine, University of ToyamaRecruiting
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Immediate necrosectomy
Step-up approach
Endoscopic necrosectomy will be conducted in the same session of EUS-guided drainage (or at least within 72 hours of randomization) and be repeated until clinical success.
Step-up treatment will be conducted if a patient's condition does not improve after EUS-guided drainage. The step-up approach includes increasing the number of stents, adding another EUS-guided drainage, and performing percutaneous drainage after 72-96 hours of the initial drainage. Endoscopic necrosectomy is considered when clinical improvement is not observed even after two times of step-up treatment.