Study Stopped
Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients)
Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
1 other identifier
interventional
602
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2009
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 9, 2009
CompletedFirst Posted
Study publicly available on registry
January 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
February 12, 2013
CompletedFebruary 28, 2013
February 1, 2013
2.5 years
January 9, 2009
January 10, 2013
February 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Post-ERCP Pancreatitis
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.
5 days
Study Arms (2)
1
ACTIVE COMPARATORIndomethacin suppository
2
PLACEBO COMPARATORPlacebo suppository
Interventions
Eligibility Criteria
You may qualify if:
- Included patients are those undergoing ERCP and have one of the following:
- Clinical suspicion of sphincter of Oddi dysfunction
- History of post-ERCP pancreatitis (at least one episode)
- Pancreatic sphincterotomy
- Pre-cut (access) sphincterotomy
- \> 8 cannulation attempts
- Pneumatic dilation of intact biliary sphincter
- Ampullectomy
- or at least 2 of the following:
- Age \< 50 years old \& female gender
- History of recurrent pancreatitis (at least 2 episodes)
- ≥3 pancreatic injections, with at least one injection to tail
- Pancreatic acinarization
- Pancreatic brush cytology
You may not qualify if:
- Unwillingness or inability to consent for the study
- Age \< 18 years
- Intrauterine pregnancy
- Breast feeding mother
- Standard contraindications to ERCP
- Allergy to Aspirin or NSAIDs
- Renal failure (Cr \> 1.4)
- Active or recent (within 4 weeks) gastrointestinal hemorrhage
- Acute pancreatitis (lipase peak) within 72 hours
- Known chronic calcific pancreatitis
- Pancreatic head malignancy
- Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
- ERCP for biliary stent removal or exchange without anticipated pancreatogram
- Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
- Anticipated inability to follow protocol
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Indiana University School of Medicinecollaborator
- University of Kentuckycollaborator
- Case Western Reserve Universitycollaborator
Study Sites (4)
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Related Publications (1)
Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
PMID: 22494121DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- B. Joseph Elmunzer, MD.
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Badih J Elmunzer, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Gastroenterology
Study Record Dates
First Submitted
January 9, 2009
First Posted
January 12, 2009
Study Start
January 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
February 28, 2013
Results First Posted
February 12, 2013
Record last verified: 2013-02