Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis
Public ClinicalTrials.gov record NCT02476279. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02476279
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,950 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2015
- Primary completion
- Jan 24, 2023
- Completion
- Jan 24, 2023
- Last update posted
- Jun 11, 2024
2015 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 17
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univesrity of Southern California | Los Angeles | California | — | — |
| University of Colorado | Denver | Colorado | — | — |
| The Florida Hospital | Orlando | Florida | — | — |
| Emory University | Atlanta | Georgia | — | — |
| Northwestern University | Chicago | Illinois | — | — |
| University of Kansas | Kansas City | Kansas | — | — |
| Johns Hopkins University | Baltimore | Maryland | — | — |
| University of Michigan | Ann Arbor | Michigan | — | — |
| Washington University | St Louis | Missouri | — | — |
| Dartmouth University | Lebanon | New Hampshire | — | — |
| Case Western Reserve University | Cleveland | Ohio | — | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | — | — |
| Oregon Health & Science University | Portland | Oregon | — | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | — | — |
| Medical University of South Carolina | Charleston | South Carolina | — | — |
| Vanderbilt University | Nashville | Tennessee | — | — |
| Virginia Mason Medical Center | Seattle | Washington | — | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02476279, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 11, 2024 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02476279 live on ClinicalTrials.gov.