Overview

Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients

Status:
Terminated
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
Summary
Inflammation of the pancreas (pancreatitis) is an uncommon but potentially serious complication of endoscopic retrograde cholangiopancreatography (ERCP), a specialized endoscopic examination of the ducts draining the liver and pancreas. Although many different strategies have been tried and studied in attempts to reduce this risk, few have been shown to make a significant difference. Those that have are either very expensive, difficult to administer, or both. Diclofenac, an anti-inflammatory medication most often used to treat arthritis, has shown potential to decrease the risk of post-ERCP pancreatitis. It can be given after the procedure to patients at most risk for the complication, and has few side effects. This study will randomize people in the study to placebo or active medication, to determine if Diclofenac reduces the incidence of pancreatitis.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Queen's University
Treatments:
Diclofenac
Criteria
Inclusion Criteria:

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 Criteria:

- 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.