Continuous regional arterial infusion (CRAI) versus venous infusion of Nafamostat mesilate for severe acute pancreatitis: a multicenter, open-label, randomized controlled trial.

Continuous regional arterial infusion (CRAI) versus venous infusion of Nafamostat mesilate for severe acute pancreatitis: a multicenter, open-label, randomized controlled trial. - A randomized controlled trial to evaluate CRAI of Nafamostat mesilate for severe acute pancreatitis (CRAI-SAP study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020868

Enrollment

Registered

2016-02-03

Start date

2016-03-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute pancreatitis

Interventions

Participants in the experimental group undergo CRAI of Nafamostat mesialte (240mg/day) to the pancreas for 5 days Participants in the control group undergo venous infusion of Nafamostat mesialte (240m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with severe acute pancreatitis who fulfill the Japanese CECT Grade 2 or 3 and who present hypo-enhanced lesion (<70HU) in more than one third of the pancreas detected by the CECT performed within 48 hours of the onset. 2. Aged between 20 and 79 years. 3. Administration of Nafamostat mesilate starts within 24 hours after the CECT. 4. Existence of legally acceptable representative.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Extent of pancreatic necrosis. CT severity index. Degree of pain. Japanese severity score. Modified Marshall score. CRP. SIRS. Rate of necrosectomy. Mortality.	—

Countries

Japan

Contacts

Public ContactMorihisa Hirota

Tohoku University Hospital Gastroenterology

morihirota@med.tohoku.ac.jp022-717-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026