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

This study is currently recruiting participants.

Verified by University of Michigan, January 2009

First Received: January 9, 2009 No Changes Posted

Sponsor:	University of Michigan
Collaborator:	Indiana University School of Medicine
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00820612

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Endoscopy

Drug Information available for: Indomethacin

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Incidence of post-ERCP pancreatitis [ Time Frame: within 48 hours after ERCP ] [ Designated as safety issue: No ]

Estimated Enrollment:	870
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Indomethacin suppository	Drug: Indomethacin 100 mg PR once at the time of ERCP
2: Placebo Comparator 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:

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

Exclusion Criteria:

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
Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820612

Contacts

Contact: Badih J Elmunzer, MD

734 615 6652

badihe@umich.edu

Locations

United States, Indiana
Indiana University Medical Center	Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Evan Fogel, MD efogel@iupui.edu
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Badih J Elmunzer, MD 734-615-6652 badihe@umich.edu
Principal Investigator: Badih J Elmunzer, MD

Sponsors and Collaborators

University of Michigan

Indiana University School of Medicine

Investigators

Principal Investigator:

Badih J Elmunzer, MD

University of Michigan

More Information

No publications provided

Responsible Party:	University of Michigan ( B. Joseph Elmunzer, MD. Clinical lecturer, Gastroenterology )
Study ID Numbers:	HUM00022847
Study First Received:	January 9, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00820612 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Reproductive Control Agents
Gout Suppressants
Pharmacologic Actions
Digestive System Diseases
Tocolytic Agents

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Indomethacin
Pancreatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pancreatitis

ClinicalTrials.gov processed this record on February 08, 2010