A randomized controlled trial to evaluate CRAI therapy for severe acute pancreatitis: Study protocol

Background: There have been few high‐quality evidences of continuous regional arterial infusion (CRAI) of Nafamostat mesialte (NM) for patients with severe acute pancreatitis, so far. Methods: An open label multicenter randomized controlled trial will be conducted. Patients who present hypo‐enhanced lesion in the pancreas detected by the contrast‐enhanced CT (CECT) performed within 48 hours of the onset, will be randomly divided into a CRAI group and a venous infusion group. The extent of pancreatic necrosis, determined by the CECT at 2 weeks after starting the NM administration, will be compared between the two groups by a blinded central committee for diagnostic imaging. Results: The registration is under way and will be closed by the end of this year.