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

This study has been terminated.

( Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients) )

First Received on January 9, 2009. Last Updated on August 3, 2011 History of Changes

Sponsor:	University of Michigan
Collaborators:	Indiana University School of Medicine University of Kentucky Case Western Reserve University
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Pancreatitis

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:	948
Study Start Date:	January 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

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

No publications provided

Responsible Party:	B. Joseph Elmunzer, MD. Clinical lecturer, Gastroenterology, University of Michigan
ClinicalTrials.gov Identifier:	NCT00820612 History of Changes
Other Study ID Numbers:	HUM00022847
Study First Received:	January 9, 2009
Last Updated:	August 3, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012