Efficacy and safety of high dose VS low dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pnacreatitis:a randomized controlled multicenter trial

Efficacy and safety of high dose VS low dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pnacreatitis:a randomized controlled multicenter trial - High and low trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020457

Enrollment

900

Registered

2016-01-06

Start date

2016-01-05

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

post ERCP pancreatitis

Interventions

Rectal administration of 0.5mg/kg diclofenac within 30 min. after ERCP Rectal administration of 1.0mg/kg diclofenac within 30 min. after ERCP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are scheduled to undergo ERCP and who undergo emergency ERCP from 8:00 to 17:30

Exclusion criteria

Exclusion criteria: emergency ERCP from 17:30 to 8:30 eGFR<50 choledocholithiasis with pancreatitis aspirin induced asthma pregnancy Triamterene oral administration <20age shock vital NSAIDs allergy

Design outcomes

Primary

Measure	Time frame
Non inferiority of Low dose VS high dose rectal diclofenac for prevention of post ERCP pancreatitis	—

Secondary

Measure	Time frame
severity of pancreatitis adverse event serum AMY level 2 hours and one day after ERCP Spread of inflamation in serum AMY high level	—

Countries

Japan

Contacts

Public ContactKusumoto Kiyonori

Kyoto Katsura Hospital Department of gastroenterology

kusumoto1024@gmail.com075-391-5811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026