Actively Recruiting
Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
Led by Tokyo University · Updated on 2022-10-27
70
Participants Needed
21
Research Sites
454 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with walled-off necrosis (WON) defined by the revised Atlanta classification
- WON longest diameter of 4 cm or larger
- Presence of at least one condition: signs of infection, gastrointestinal symptoms, abdominal symptoms, or obstructive jaundice
- Need for drainage treatment for WON
- Age 18 years or older
- Informed consent provided by patient or representative
- Patients visiting or hospitalized at participating institutions
You will not qualify if you...
- WON inaccessible by endoscopic ultrasonography (EUS)-guided approach
- AXIOS stent already placed into WON before enrollment
- Severe coagulopathy with platelet count under 50,000/mm3 or prothrombin time INR over 1.5
- Use of antithrombotic agents that cannot be managed per guidelines
- Inability to tolerate endoscopic procedures
- Pregnant women
- Considered inappropriate for inclusion by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Department of Gastroenterology, The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan, 113-8655
Not Yet Recruiting
2
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Tokyo, Japan
Actively Recruiting
3
Department of Gastroenterology, Aichi Medical University
Aichi, Japan
Actively Recruiting
4
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Chiba, Japan
Actively Recruiting
5
Department of Gastroenterology, Gifu Municipal Hospital
Gifu, Japan
Actively Recruiting
6
Department of Gastroenterology, Gifu Prefectural General Medical Center
Gifu, Japan
Actively Recruiting
7
First Department of Internal Medicine, Gifu University Hospital
Gifu, Japan
Not Yet Recruiting
8
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University
Hyōgo, Japan
Actively Recruiting
9
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Kagawa, Japan
Actively Recruiting
10
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
Kagoshima, Japan
Actively Recruiting
11
Department of Gastroenterology, Kameda Medical Center
Kamogawa, Japan
Actively Recruiting
12
Department of Gastroenterological Endoscopy, Kanazawa Medical University
Kanazawa, Japan
Not Yet Recruiting
13
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Kawagoe, Japan
Not Yet Recruiting
14
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Kawasaki, Japan
Not Yet Recruiting
15
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Kobe, Japan
Actively Recruiting
16
Department of Gastroenterology, Yuuai Medical Center
Okinawa, Japan
Actively Recruiting
17
2nd Department of Internal Medicine, Osaka Medical College
Osaka, Japan
Not Yet Recruiting
18
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Ōsaka-sayama, Japan
Not Yet Recruiting
19
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Sapporo, Japan
Actively Recruiting
20
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Tokyo, Japan
Not Yet Recruiting
21
Third Department of Internal Medicine, University of Toyama
Toyama, Japan
Actively Recruiting
Research Team
Y
Yousuke Nakai
CONTACT
T
Tomotaka Saito
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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