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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02476279
Recruitment Status : Recruiting
First Posted : June 19, 2015
Last Update Posted : June 28, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Badih Elmunzer, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE June 19, 2015
Last Update Posted Date June 28, 2022
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
The proportion of subjects in each study group with post-ERCP pancreatitis [ Time Frame: Within 48 hours after ERCP ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
The proportion of subjects in each study group with moderate-severe post-ERCP pancreatitis [ Time Frame: Within one month of ERCP ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis
Official Title  ICMJE Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Post-ERCP Pancreatitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Indomethacin alone
    Indomethacin 100 mg rectally immediately after ERCP
    Intervention: 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
    Intervention: Other: Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
Publications * Elmunzer BJ, Serrano J, Chak A, Edmundowicz SA, Papachristou GI, Scheiman JM, Singh VK, Varadarajulu S, Vargo JJ, Willingham FF, Baron TH, Coté GA, Romagnuolo J, Wood-Williams A, Depue EK, Spitzer RL, Spino C, Foster LD, Durkalski V; SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial. Trials. 2016 Mar 3;17(1):120. doi: 10.1186/s13063-016-1251-2. Erratum in: Trials. 2020 Jun 3;21(1):471.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2021)
2180
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2015)
1430
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: B. Joseph Elmunzer, MD elmunzer@musc.edu
Contact: Rebecca Spitzer, MPH 843-876-4303 spitzer@musc.edu
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02476279
Other Study ID Numbers  ICMJE U01DK104833-01( U.S. NIH Grant/Contract )
U01DK104833-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Badih Elmunzer, Medical University of South Carolina
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of South Carolina
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP