Status:
TERMINATED
Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients
Lead Sponsor:
Queen's University
Conditions:
Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Inflammation of the pancreas (pancreatitis) is an uncommon but potentially serious complication of endoscopic retrograde cholangiopancreatography (ERCP), a specialized endoscopic examination of the du...
Detailed Description
Hypothesis: Diclofenac, when administered immediately post ERCP in patients at higher risk of developing post-ERCP pancreatitis, will significantly reduce the incidence of this complication. Interve...
Eligibility Criteria
Inclusion
- These were chosen based on a review of the major studies evaluating risk factors for post-ERCP pancreatitis. Any of the following factors placing a patient at high risk (\>10%) of post ERCP pancreatitis:
- Patient characteristics: Prior history of post-ERCP pancreatitis, prior history of acute pancreatitis, suspected Sphincter of Oddi dysfunction, or normal bilirubin;
- Procedure related factors: Moderate (6-15 attempts) and difficult (\>15 attempts) bile duct cannulation, balloon dilation of the biliary sphincter, pre-cut papillotomy, pancreatic sphincterotomy.
Exclusion
- Ongoing acute or chronic pancreatitis;
- Previous biliary sphincterotomy;
- Contra-indications to non-steroidal anti-inflammatory medications (allergy, reduced renal function, recent upper gastrointestinal bleeding);
- Ingestion of an NSAID ( nonsteroidal anti-inflammatory drug) in the previous 7 days.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00428025
Start Date
October 1 2006
End Date
October 1 2008
Last Update
September 22 2015
Active Locations (1)
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1
Kingston General Hospital
Kingston, Ontario, Canada