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A comparative study of 24-hour and 6-hour Infusion of Nafamostat Mesilate for Prevention of Post-ERCP Pancreatitis

A comparative study of 24-hour and 6-hour Infusion of Nafamostat Mesilate for Prevention of Post-ERCP Pancreatitis: a Prospective Randomized Comparison Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0001625
Enrollment
256
Registered
2015-09-16
Start date
2012-11-05
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : 20mg of nafamostat mesilate (Futhan, SK Chemicals, Seoul, Korea) dissolved in 500ml of 5% dextrose solution was used in both group. Infusion began within an hour before ERCP and was continued f

Sponsors

Pusan National University Yangsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients with an intact papilla and known or suspected pancreatobiliary disease, who are candidates for therapeutic or diagnostic biliary ERCP at a single tertiary referral center (Pusan National University Yangsan Hospital), were scheduled to participate in the study.

Exclusion criteria

Exclusion criteria: Patients were excluded for any of the following reasons: age younger than 18 years, previous history of precut or biliary sphicterotomy, previous history of biliary or pancreatic stenting, repeated ERCP, clinical evidence of acute pancreatitis at the time of procedure, treatment with nafamostat mesilate or other protease inhibitors in the last 7 days, pregnancy and refusal to participate.

Design outcomes

Primary

MeasureTime frame
post ERCP pancreatitis incidence, post ERCP pancreatitis severity, serum amylase/lipase level, abdominal pain

Secondary

MeasureTime frame
diagnostic procedures, therapeutic procedures, examination time, and number of injection or cannulation of the pancreatic duct, placement of prophylactic pancreatic stent

Countries

Korea, Republic of

Contacts

Public ContactSU JIN KIM

Pusan National University Yangsan Hospital

endoksj@gmail.com+82-55-360-1535

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026