walled-off necrosis (WON) WON
Conditions
Interventions
Off-label use of hydrogen peroxide during endoscopic treatments for WON
Sponsors
Takahara Naminatsu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnose with WON by contrast CT based on revised Atlanta classification (diagnosis by non-contrast CT or MRI is allowed if participants have contraindications for contrast CT) (2) Judged to be treated with drainage due to symptoms: fever, stomach pain, bloating or other bowel obstruction symptoms, jaundice (3) Aged 18 years and above at the time of informed consent (4) Male or female (5) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation
Exclusion criteria
Exclusion criteria: (1) Not suitable for endoscopy, as follows: 1. Judge that endoscopic and percutaneous approaches to WON are impossible by clinical investigators 2. With hemorrhagic diathesis: platelet 1.5 3. Taking antithrombotic therapy and unable to stop or change the antithrombotic drugs following Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment 4. Judged that it is impossible to perform endoscopic and percutaneous treatment safely by clinical investigators (2) With a history of severe drug allergy including anaphylactic shock, or a history of severe side effects (3) With allergy to components of study drug (4) Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of moderate or severe adverse events during hospitalization | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Rate of clinical success (defined as lesion shrinkage and symptom improvement) (2) Length of treatment (3) Incidence of clinical events (4) Length of hospitalization (5) Incidence of adverse events | — |
Contacts
Public ContactTomotaka Saito
The University of Tokyo Hospital
Outcome results
None listed