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Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis (SVI)

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ClinicalTrials.gov Identifier: NCT02476279
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Badih Elmunzer, Medical University of South Carolina

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Post-ERCP Pancreatitis Other: Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement Other: Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial
Study Start Date : September 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Indomethacin alone
Indomethacin 100 mg rectally immediately after ERCP
Other: Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement
Active Comparator: Indomethacin+pancreatic stent
Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
Other: Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement



Primary Outcome Measures :
  1. The proportion of subjects in each study group with post-ERCP pancreatitis [ Time Frame: Within 48 hours after ERCP ]

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  1. Clinical suspicion of or known sphincter of Oddi dysfunction
  2. History of post-ERCP pancreatitis (at least one prior episode of pancreatitis after ERCP)
  3. Pancreatic sphincterotomy
  4. Pre-cut (access) sphincterotomy (freehand pre-cut and septotomy)
  5. 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).
  6. Short-duration (≤ 1 min) balloon dilation of an intact biliary sphincter.

    Or has at least 2 of the following:

  7. Age < 50 years old & female gender
  8. History of recurrent pancreatitis (at least 2 episodes)
  9. ≥3 pancreatic injections
  10. Pancreatic acinarization
  11. Pancreatic brush cytology

Exclusion Criteria:

  1. Ampullectomy
  2. Cases in which a pancreatic stent must be placed for therapeutic intent
  3. Unwillingness or inability to consent for the study
  4. Pregnancy
  5. Breast feeding mother
  6. Standard contraindications to ERCP
  7. Allergy to Aspirin or NSAIDs
  8. Known renal failure (Cr > 1.4 mg/dl)
  9. Ongoing or recent (within 2 weeks) hospitalization for gastrointestinal hemorrhage
  10. Ongoing or recent (within 1 week) hospitalization for acute pancreatitis
  11. Known chronic calcific pancreatitis
  12. Pancreatic head malignancy
  13. Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (no manipulation of minor papilla)
  14. ERCP for biliary stent removal or exchange without anticipated pancreatogram
  15. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
  16. Anticipated inability to follow protocol
  17. Absence of rectum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476279


Contacts
Contact: B. Joseph Elmunzer, MD elmunzer@musc.edu
Contact: April Williams-Wood 843-876-4303 woodap@musc.edu

Locations
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States
Contact: Sachin Wani         
United States, Florida
The Florida Hospital Recruiting
Orlando, Florida, United States
Contact: Shyam Varadarajulu         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States
Contact: Field Willingham         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States
Contact: Vikesh Singh         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States
Contact: James Schieman         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States
Contact: Steve Edmundowicz         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States
Contact: Amitabh Chak         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Georgios Papachristou         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
Contact: Joe Elmunzer         
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Badih Elmunzer, Associate Professor of Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02476279     History of Changes
Other Study ID Numbers: U01DK104833-01 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Pancreatitis
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action