Continuous regional arterial infusion (CRAI) versus venous infusion of Nafamostat mesilate for severe acute pancreatitis: a multicenter, open-label, randomized controlled trial.
Phase 2
- Conditions
- Severe acute pancreatitis
- Registration Number
- JPRN-UMIN000020868
- Lead Sponsor
- Tohoku University Hospital, Division of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1. Previous CRAI therapy for the same disease. 2. Previous therapy using Nafamostat mesilate >39mg/kg/day, Gabexate mesilate >39mg/kg/day or Ulinastatin >300,000U/day for the same disease. 3. Unclear the starting time of severe abdominal pain. 4. Patient with concurrent pancreatic cancer. 5. History of the pancreas resection. 6. eGFR<30mL/min/1.73m2. 7. Serous K>5.5mEq/L. 8. Pregnancy. 9. Allergy to iodine contrast medium. 10. Contraindication for angiography. 11. Allergy to Nafamostat mesilate. 12. Untolerable quality of CT image. 13. Serious underlying disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of large extent of pancreatic necrosis determined by masked assessors using contrast-enhanced CT (CECT) images obtained at 2 weeks after starting the Nafamostat mesilate administration.
- Secondary Outcome Measures
Name Time Method Extent of pancreatic necrosis. CT severity index. Degree of pain. Japanese severity score. Modified Marshall score. CRP. SIRS. Rate of necrosectomy. Mortality.