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

This study has been terminated.
(Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients))
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
ClinicalTrials.gov Identifier:
NCT00820612
First received: January 9, 2009
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Post-ERCP Pancreatitis
Drug: Indomethacin
Other: Placebo suppositories
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Post-ERCP Pancreatitis [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 602
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided by University of Michigan

Additional 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
Study First Received: January 9, 2009
Results First Received: January 10, 2013
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014