Prevention of Post-ERCP Pancreatitis by Intraduodenal Indomethacin in ERCP naïve patients

Prevention of Post-ERCP Pancreatitis by Intraduodenal Indomethacin in ERCP naïve patients: Prospective, Randomized, Placebo-controlled, Double blind, Multicenter Study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002394

Enrollment

926

Registered

2017-07-28

Start date

2017-05-08

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 : When duodenoscope reaches to major papilla, indomethacin 100mg or placebo dissoved in 20 mL of saline will be sprayed in duodenum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age = 20 or age = 80, 2) Patients with naïve papilla and first ERCP, 3) Diagnostic or therapeutic ERCP, 4) No evidence of significant abnormality in cardiopulmonary function, 5) No expectation of adverse event after indomethacin application.

Exclusion criteria

Exclusion criteria: 1) Unwillingness or inability to informed consent for study, 2) Age < 20 or > 80, 3) Pregnant women, 4) Lactating women, 5) Clinical contraindication for ERCP, 6) History of allergy or hypersensitivity to aspirin or NSAIDs, 7) Recent history (within 7 days) of NSAIDs medication, 8) Serum creatinine > 1.4 mg/dL, 9) Active or recent (within 4 weeks) gastrointestinal bleeding, 10) Active cardiovascular or cerebrovascular disease, 11) Acute pancreatitis within 72 hours, 12) Chronic pancreatitis, 13) ERCP for stent removal or stent change, 14) Endoscopic sphicterotomy state, 15) Drug or alcohol abuser, 16) Psychiatric illness that anticipated inability to follow study protocol.

Design outcomes

Primary

Measure	Time frame
Rate of post-ERCP pancreatitis	—

Secondary

Measure	Time frame
Safety profile of indomethacin	—

Countries

Korea, Republic of

Contacts

Public ContactHyoung-Chul Oh

Chung-Ang Univerisity Hospital

ohc7108@naver.com+82-2-6299-3149

Outcome results