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A randomized trial of low-dose rectal diclofenac for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis

A randomized trial of low-dose rectal diclofenac for prevention of post endoscopic retrograde cholangiopancreatography pancreatitis - A randomized trial of rectal diclofenac for prevention of post ERCP pancreatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004658
Enrollment
230
Registered
2010-12-02
Start date
2009-03-01
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

Diclofenac group is administered with 50 mg of rectal diclofenac 30 min before ERCP with saline infusion (for patients weighing less than 50 kg, the dose of diclofenac was reduced to 25 mg). Control

Sponsors

Saga Prefectural Hospital KOSEIKAN
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are planned ERCP.

Exclusion criteria

Exclusion criteria: Patients with acute or chronic pancreatitis. Patients with a history of endoscopic sphincterotomy. Patients who are diagnosed peptic ulcer disease. Patients with a history of aspirin-induced asthma. Patients with rectal diseases. Patients who are treated with triamterene. Pregnant and breast-feeding women. Patients who had taken NSAIDs during preceding week. Patients with a history of hypersensitivity to NSAIDs. Patients with a severe renal dysfunction.

Design outcomes

Primary

MeasureTime frame
The occurrence of PEP as defined by the criteria of Cotton as the development of abdominal pain and elevation of serum amylase level greater than three times the upper normal limit within 24 hours after ERCP

Countries

Japan

Contacts

Public ContactTaiga Otsuka

Saga Prefectural Hospital KOSEIKAN Hepatobiliary and Pancreatic Medicine

Outcome results

None listed

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