Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
Recruiting · NCT05451901 · Interventional (participants receive a specific treatment) · Lead sponsor: Tokyo University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
21 locations listed.
- 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, 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
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine - Ōsaka-sayama, 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