- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02476279
Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis (SVI)
Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial
Background: Pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality, and increased health care expenditures. Until recently, the only effective method of preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement (PSP), an intervention that is costly, time consuming, technically challenging, and potentially dangerous. The investigators recently reported the results of a large randomized controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (>80%) had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who received indomethacin alone were less likely to develop PEP than those who received a pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for underlying differences in subject risk. If indomethacin were to obviate the need for PSP, major clinical and cost benefits in ERCP practice could be realized.
Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP pancreatitis in high-risk cases.
Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared. In addition, the investigators will establish a quality-assured central repository of biological specimens obtained from study participants, permitting future translational research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms by which non-steroidal anti-inflammatory drugs prevent this complication.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: B. Joseph Elmunzer, MD
- Email: elmunzer@musc.edu
Study Contact Backup
- Name: Rebecca Spitzer, MPH
- Phone Number: 843-876-4303
- Email: spitzer@musc.edu
Study Locations
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Calgary, Canada
- University of Calgary
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Montreal, Canada
- McGill University
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California
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Los Angeles, California, United States
- Univesrity of Southern California
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Colorado
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Denver, Colorado, United States
- University of Colorado
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Florida
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Orlando, Florida, United States
- The Florida Hospital
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Georgia
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Atlanta, Georgia, United States
- Emory University
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Illinois
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Chicago, Illinois, United States
- Northwestern University
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Kansas
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Kansas City, Kansas, United States
- University of Kansas
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Maryland
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Baltimore, Maryland, United States
- Johns Hopkins University
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Michigan
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Ann Arbor, Michigan, United States
- University of Michigan
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Missouri
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Saint Louis, Missouri, United States
- Washington University
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New Hampshire
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Lebanon, New Hampshire, United States
- Dartmouth University
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Ohio
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Cleveland, Ohio, United States
- Case Western Reserve University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- University of Pittsburgh
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South Carolina
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Charleston, South Carolina, United States
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, United States
- Vanderbilt University
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Washington
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Seattle, Washington, United States
- Virginia Mason Medical Center
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Wisconsin
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Milwaukee, Wisconsin, United States
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Any patient undergoing ERCP in whom pancreatic stent placement is planned for post-ERCP pancreatitis prevention, is ≥ 18 years old, who provides informed consent, AND:
Has one of the following:
- Clinical suspicion of or known sphincter of Oddi dysfunction
- History of post-ERCP pancreatitis (at least one prior episode of pancreatitis after ERCP)
- Pancreatic sphincterotomy
- Pre-cut (access) sphincterotomy (freehand pre-cut and septotomy)
- Difficult cannulation: cannulation duration ≥ 6 minutes (starting at time of initial papillary engagement with at least 25% of the time in contact with the papilla) AND/OR ≥ 6 cannulation attempts (defined as sustained contact with papilla lasting at least 1 second).
Short-duration (≤ 1 min) balloon dilation of an intact biliary sphincter.
Or has at least 2 of the following:
- Age < 50 years old & female gender
- History of recurrent pancreatitis (at least 2 episodes)
- ≥3 pancreatic injections
- Pancreatic acinarization
- Pancreatic brush cytology
Exclusion Criteria:
- Ampullectomy
- Cases in which a pancreatic stent must be placed for therapeutic intent
- Unwillingness or inability to consent for the study
- Pregnancy
- Breast feeding mother
- Standard contraindications to ERCP
- Allergy to Aspirin or NSAIDs
- Known renal failure (Cr > 1.4 mg/dl)
- Ongoing or recent (within 2 weeks) hospitalization for gastrointestinal hemorrhage
- Ongoing or recent (within 1 week) hospitalization for acute pancreatitis
- Known chronic calcific pancreatitis
- Pancreatic head malignancy
- Procedure performed on major papilla/ventral pancreatic duct in patient 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
- Absence of rectum
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Indomethacin alone
Indomethacin 100 mg rectally immediately after ERCP
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Active Comparator: Indomethacin+pancreatic stent
Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of subjects in each study group with post-ERCP pancreatitis
Time Frame: Within 48 hours after ERCP
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Within 48 hours after ERCP
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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The proportion of subjects in each study group with moderate-severe post-ERCP pancreatitis
Time Frame: Within one month of ERCP
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Within one month of ERCP
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pancreatic Diseases
- Pancreatitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
Other Study ID Numbers
- U01DK104833-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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