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Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00820612
Recruitment Status : Terminated (Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients))
First Posted : January 12, 2009
Results First Posted : February 12, 2013
Last Update Posted : February 28, 2013
Sponsor:
Collaborators:
Indiana University School of Medicine
University of Kentucky
Case Western Reserve University
Information provided by (Responsible Party):
Badih Joseph Elmunzer, University of Michigan

Brief Summary:

Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.

Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.


Condition or disease Intervention/treatment Phase
Post-ERCP Pancreatitis Drug: Indomethacin Other: Placebo suppositories Phase 4

Detailed Description:
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Study Start Date : January 2009
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Indomethacin suppository
Drug: Indomethacin
100 mg PR once at the time of ERCP
Placebo Comparator: 2
Placebo suppository
Other: Placebo suppositories
2 placebo suppositories at the time of ERCP



Primary Outcome Measures :
  1. Post-ERCP Pancreatitis [ Time Frame: 5 days ]
    Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Included patients are those undergoing ERCP and have one of the following:

  1. Clinical suspicion of sphincter of Oddi dysfunction
  2. History of post-ERCP pancreatitis (at least one episode)
  3. Pancreatic sphincterotomy
  4. Pre-cut (access) sphincterotomy
  5. > 8 cannulation attempts
  6. Pneumatic dilation of intact biliary sphincter
  7. Ampullectomy

or at least 2 of the following:

  1. Age < 50 years old & female gender
  2. History of recurrent pancreatitis (at least 2 episodes)
  3. ≥3 pancreatic injections, with at least one injection to tail
  4. Pancreatic acinarization
  5. Pancreatic brush cytology

Exclusion Criteria:

  1. Unwillingness or inability to consent for the study
  2. Age < 18 years
  3. Intrauterine pregnancy
  4. Breast feeding mother
  5. Standard contraindications to ERCP
  6. Allergy to Aspirin or NSAIDs
  7. Renal failure (Cr > 1.4)
  8. Active or recent (within 4 weeks) gastrointestinal hemorrhage
  9. Acute pancreatitis (lipase peak) within 72 hours
  10. Known chronic calcific pancreatitis
  11. Pancreatic head malignancy
  12. Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
  13. ERCP for biliary stent removal or exchange without anticipated pancreatogram
  14. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
  15. Anticipated inability to follow protocol
  16. Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820612


Locations
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University of Michigan
Indiana University School of Medicine
University of Kentucky
Case Western Reserve University
Investigators
Principal Investigator: Badih J Elmunzer, MD University of Michigan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Badih Joseph Elmunzer, Assistant Professor, Gastroenterology, University of Michigan
ClinicalTrials.gov Identifier: NCT00820612     History of Changes
Other Study ID Numbers: HUM00022847
First Posted: January 12, 2009    Key Record Dates
Results First Posted: February 12, 2013
Last Update Posted: February 28, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action