Comparative study of intravenous ketorolac tromethamine and insertion of pancreatic duct stent to prevent post-ERCP pancreatitis : pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000761

Enrollment

360

Registered

2013-05-31

Start date

2013-05-31

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, Medical Device : In the first phase of this study, we will administer intravenously ketorolac tromethamine (KETOR) for study group and normal saline for control group, 10mg at immediately and 30

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patient with disease for which endoscopic retrograde cholangiopancreatogram is indicated for diagnosis or treatment

Exclusion criteria

Exclusion criteria: 1) Unwillingness or inability to consent for the study 2) Age 75 years 3) Intrauterine pregnancy 4) Breast feeding mother 5) Standard contraindications to ERCP 6) Allergy to Aspirin or NSAIDs 7) Renal failure (Cr > 1.4) 8) Active or recent (within 4 weeks) gastrointestinal hemorrhage 9) Existing acute pancreatitis within 72 hours prior to ERCP 10) Known chronic calcific pancreatitis 11) Pancreatic head malignancy 12) congenital anomaly of pancreatobiliary system 13) ERCP for biliary stent removal or exchange 14) Subjects with prior biliary sphincterotomy

Design outcomes

Primary

Measure	Time frame
incidence of post-ERCP pancreatitis	—

Secondary

Measure	Time frame
side effects of ketorolac tromethamine and complications of insertion of pancreatic duct stent	—

Countries

Korea, Republic of

Contacts

Public ContactSung-Won Jung

Hallym University Medical Center-Kangnam

Outcome results