Clinical trial NCT00820612: Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
Official title: A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Post-ERCP Pancreatitis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
name: University of Kentucky
name: Case Western Reserve University
First posted: 2009-01-12
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Post-ERCP Pancreatitis
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University of Michigan
name: Badih J Elmunzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.