A study comparing Ulinastatin with standard treatment to prevent pancreatitis after ERCP in patients undergoing the procedure

INTERVENTION: Intervention1: Intravenous Ulinastatin plus Standard Preventive Therapy: articipants randomized to the intervention arm will receive intravenous Ulinastatin 150000 IU diluted in 100 mL of 5 percent glucose or 0.9 percent normal saline administered by slow intravenous infusion over 1 hour and completed 30 minutes before ERCP. For patients identified as high risk during the procedure, the infusion will be started during ERCP. All participants will also receive standard preventive therapy consisting of rectal diclofenac 100 mg before ERCP, intravenous hydration with lactated Ringer solution, and prophylactic pancreatic duct stenting when clinically indicated. Control Intervention1: Placebo plus Standard Preventive Therapy: Participants randomized to the control arm will receive a matching intravenous placebo diluted in 100 mL of 5 percent glucose or 0.9 percent normal saline administered over 1 hour using the same schedule as the intervention group, together with standard preventive therapy including rectal diclofenac, intravenous hydration, and prophylactic pancreatic duct stenting when clinically indicated. CONDITION: Health Condition 1: K858‐ Other acute pancreatitis PRIMARY OUTCOME: Incidence of post ERCP pancreatitisTimepoint: 24 hr, Day 3 or Discharge Day, Day 30 SECONDARY OUTCOME: Incidence of hyperenzymemiaTimepoint: At 24 hours Incidence of other ERCP‐related adverse eventsTimepoint: Upto 30th day of ERCP Length of hospital stayTimepoint: From admission to discharge MortalityTimepoint: Upto 30th day of ERCP Severity of PEPTimepoint: Upto 30th day of ERCP Total hospitalization costTimepoint: At discharge INCLUSION CRITERIA: 1 Patients at least 18 years of age and at high risk for PEP 2 Willing to participate in the study