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Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients
This study is currently recruiting participants.
Verified by Queen's University, December 2008
First Received: January 25, 2007   Last Updated: December 8, 2008   History of Changes
Sponsored by: Queen's University
Information provided by: Queen's University
ClinicalTrials.gov Identifier: NCT00428025
  Purpose

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.


Condition Intervention Phase
Pancreatitis
Drug: diclofenac
Drug: placebo
Phase IV

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients: A Prospective, Randomized, Double Blind, Placebo Controlled Trial.

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • post-ercp pancreatitis [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • severity of pancreatitis, side effects [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
placebo suppository
Drug: placebo
similar shape and size suppository
2: Active Comparator
diclofenac suppository
Drug: diclofenac
100 mg diclofenac rectal suppository

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 in the previous 7 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428025

Contacts
Contact: Lawrence Hookey, MD (613) 544-3400 ext 2288 hookeyl@hdh.kari.net
Contact: Brenda Delonghi (613) 544-3400 ext 2288 delonghb@hdh.kari.net

Locations
Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada
Principal Investigator: Lawrence Hookey, MD            
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Lawrence Hookey, MD Queen's University
  More Information

No publications provided

Responsible Party: Queen's University ( Dr. Lawrence Hookey )
Study ID Numbers: diclofenac trial hookey
Study First Received: January 25, 2007
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00428025     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
pancreatitis

Study placed in the following topic categories:
Anti-Inflammatory Agents
Digestive System Diseases
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Diclofenac
Pancreatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Pancreatitis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Pharmacologic Actions
Digestive System Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Pancreatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Pancreatitis

ClinicalTrials.gov processed this record on May 07, 2009