Efficacy of intramuscular diclofenac in the prevention of post-ERCP pancreatitis

Efficacy of intramuscular diclofenac in the prevention of post-ERCP pancreatitis: a prospective, randomized, multicencer study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001175

Enrollment

1544

Registered

2014-07-23

Start date

2014-05-19

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 : Exprimental group receives injection of 75mg of diclofenac intramuscularly just before the start of the procedure. Control group will not receive any medications.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who agree to consent for the study Intact major papilla

Exclusion criteria

Exclusion criteria: 1) Unwillingness or inability to consent for the study 2) Procedure performed on major papilla previously 3) Standard contraindications to ERCP 4) ERCP for biliary stent removal or exchange without anticipated pancreatogram 5) Acute pancreatitis or acute exacerbation of chronic pancreatitis, elevatation of amylase or lipase level above three fold of upper normal limit within 72 hours 6) Underlying severe heart, lung or endocrine disorder 7) Severe abnormality in liver function 8) Hematologic disorder 9) Pregnancy or possibility of pregnancy 10) Received Non-Steroidal Anti-Inflammatory Drugs in prior 7 days (aspirin 325 mg or less OK) 11) Contraindication to Non-Steroidal Anti-Inflammatory Drugs (Renal failure (Cr > 1.4) or Active or recent gastrointestinal hemorrhage) 12) Allergy / hypersensitivity to aspirin or Non-Steroidal Anti-Inflammatory Drugs

Design outcomes

Primary

Measure	Time frame
Compare incidence of post ERCP pancreatitis in each group	—

Secondary

Measure	Time frame
Compare incidence of moderate to severe or severe pancreatitis;Compare side effect of drug in each group	—

Countries

Korea, Republic of

Contacts

Public ContactSung Bum Kim

Yeongnam University Medical Center

Outcome results