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

NCT00428025 | Terminated Phase 4

• 1 other identifier: diclofenac trial hookey
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pancreatitis

Keywords

pancreatitis

Outcome Measures

Primary Outcomes (1)

• post-ercp pancreatitis

  24 hours

Secondary Outcomes (1)

• severity of pancreatitis, side effects

  30 days

Study Arms (2)

placebo suppository

PLACEBO COMPARATOR

Drug: placebo

diclofenac suppository

ACTIVE COMPARATOR

Drug: diclofenac

Interventions

diclofenac DRUG

100 mg diclofenac rectal suppository

diclofenac suppository

placebo DRUG

similar shape and size suppository

placebo suppository

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, Canada

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Lawrence Hookey, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: October 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

CA (1)