Pancreatic walled-off necrosis (WON)
Conditions
Interventions
Lavage using hydrogen peroxide during endoscopic interventions for WON
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with WON according to the Revised Atlanta classification (Banks PA et al. Gut 2013;62:102-11) 2. Patients with symptoms associated with WON (e.g., fever, abdominal pain, abdominal distention, GI obstruction, obstructive jaundice) requiring endoscopic drainage
Exclusion criteria
Exclusion criteria: 1. Patients for whom endoscopic interventions are not suitable, including the following 1) Endoscopic or percutaneous approach to WON is not possible 2) Bleeding tendency (platelet count <50000/mm3 or PT-INR >1.5) 3) Antithrombotic agents cannot be discontinued according to the recommendations by the Japan Gastroenterological Endoscopy Society 4) Investigators consider that patients are not suitable for endoscopic or percutaneous treatment of WON 2. A history of severe allergic reactions (e.g., anaphylactic shock) to drugs 3. A history of an allergic reaction to hydrogen peroxide 4. Investigators consider that patients are not eligible for this study for any reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Moderate or severe adverse events during the index hospitalization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical success (defined as a WON reduction in size with relief of symptoms) 2. Time to clinical success (treatment period) 3. Length of stay 4. All adverse events | — |
Countries
Japan
Contacts
Public ContactTomotaka Saito
The University of Tokyo Hospital Department of Gastroenterology
Outcome results
None listed