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

This study has been terminated.
(slow recruitment)
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00428025
First received: January 25, 2007
Last updated: February 3, 2010
Last verified: February 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients: A Prospective, Randomized, Double Blind, Placebo Controlled Trial.

Resource links provided by NLM:


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 ]

Enrollment: 23
Study Start Date: October 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo suppository
N/A
Drug: placebo
similar shape and size suppository
Active Comparator: diclofenac suppository
N/A
Drug: diclofenac
100 mg diclofenac rectal suppository

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.

Intervention:

All patients undergoing ERCP not having exclusion criteria will be approached for participation prior to the procedure. At the end of the procedure, prior to transfer from the endoscopy suite, within 15 minutes of the end of the procedure, if the patient meets inclusion criteria, a study suppository will be administered.

The suppositories will be prepared by a study pharmacist according to a randomization list prepared by an independent biostatistician. They will be randomized using a permuted block design, in blocks of 20. The placebo is inert, and identical to the study medication, a 100 mg diclofenac rectal suppository. The code will not be broken until enrolment of patients is complete.

Patients, endoscopists, nurses, and the principal investigator will all be blinded to the randomization code.

Outcomes:

Post-ERCP acute pancreatitis is the primary outcome. Consensus definition of this is new typical (epigastric/retroperitoneal) pain combined with an elevation of serum lipase or amylase >3 times the upper limit of normal. Pain will be assessed through history and physical exam by an attending gastroenterologist the morning after the procedure, with documentation in the chart and research form of the presence or absence of pain. Serum amylase will be measured the morning after the procedure, between 7 and 10 am (approximately 18 hours post procedure). Most patients will be inpatients but outpatients will be included if they can be assessed through clinical exam and blood chemistry analysis the following morning. Patients will be contacted one week after the procedure to ensure no episode of abdominal pain or bleeding has been missed.

Statistics and Power Calculation

A two sided Fisher's Exact Test will be used to compare the proportion of patients developing post-ERCP pancreatitis in each group (placebo vs. active drug).

In the population selected, the estimated risk of pancreatitis is 15%. To demonstrate a decrease to 5%, 141 patients will be required in each group, with 80% power and an alpha error 0.05. Secondary outcomes will include severity of pancreatitis, hyperamylasemia, length of stay, and mortality. Safety data regarding renal function and GI bleeding will also be collected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 in the previous 7 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428025

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

No publications provided

Responsible Party: Dr. Lawrence Hookey, Queen's University
ClinicalTrials.gov Identifier: NCT00428025     History of Changes
Other Study ID Numbers: diclofenac trial hookey
Study First Received: January 25, 2007
Last Updated: February 3, 2010
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
pancreatitis

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

ClinicalTrials.gov processed this record on July 23, 2014