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

• ClinicalTrials.gov Identifier: NCT00820612
• Recruitment Status: Terminated
• First Posted: January 12, 2009
• Results First Posted: February 12, 2013
• Last Update Posted: February 28, 2013
• Sponsor: University of Michigan
• Collaborators: Indiana University School of Medicine; University of Kentucky; Case Western Reserve University
• Information provided by (Responsible Party): Badih Joseph Elmunzer, University of Michigan

Study Description

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 Design

• 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
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Contacts and Locations

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Badih Joseph Elmunzer, Assistant Professor, Gastroenterology, University of Michigan
• ClinicalTrials.gov Identifier: NCT00820612
• Other Study ID Numbers: HUM00022847
• First Posted: January 12, 2009
• 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