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effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial-

effectiveness of prophylaxis of post-ercp pancreatitis by a rectal diclofenac and sublingual nitrate.-randomized controlled multicenter trial- - a randomized trial of rectal diclofenac and sublingual nitrate for prevention of post ercp pancreatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016274
Enrollment
900
Registered
2015-02-05
Start date
2015-03-18
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 pancretitis

Interventions

patients received a 5mg of sublingual nitrate before ERCP and received a suppository containing 50mg of diclofenac after ERCP. patients received a suppository containing 50mg of diclofenac after ERC

Sponsors

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are planned ERCP

Exclusion criteria

Exclusion criteria: 1)Patients with performance status 4. 2)Age<20 3)Body weight<50Kg 4)Patients who cannot access to Vater,s papilla. 5)Patients with a history of EST and EPBD. 6)Patients with acute pancreatitis 7)Patients with chronic pancreatitis 8)Patients with pancreatic head tumor 9)Patients who performed operation of reconstraction for intestinal track by gastrectomy. 10) Patients who had a contraindication to the use of NSAIDs and nitrate. 11) Patients who were already taking nitrates. 12)Patietns without informed concent. 13)Patients who are judged inappropriate by chief medical examiner.

Design outcomes

Primary

MeasureTime frame
Incidence rate of post-ERCP pancreatitis

Countries

Japan

Contacts

Public ContactTakeshi Tomoda

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Department of Gastroenterology & Hepatology

tomotake79@yahoo.co.jp086-235-7219

Outcome results

None listed

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