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

Post-ERCP Pancreatitis Clinical Trial

Official title:

A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00820612
• Other study ID #: HUM00022847
• Status: Terminated
• Phase: Phase 4
• First received: January 9, 2009
• Last updated: February 21, 2013
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 602
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Pancreatitis

Intervention

Drug:
• Indomethacin
100 mg PR once at the time of ERCP

Other:
• Placebo suppositories
2 placebo suppositories at the time of ERCP

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	University of Kentucky	Lexington	Kentucky

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Case Western Reserve University, Indiana University School of Medicine, University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No