Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis

ClinicalTrials.gov ID: NCT02476279

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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
Lead sponsor: Medical University of South Carolina; Other
Enrollment: 1,950 participants

Conditions and interventions

Conditions

Post-ERCP Pancreatitis

Interventions

Other

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: Sep 2015 (Actual)
Primary completion: Jan 25, 2023 (Actual)
Completion: Jan 25, 2023 (Actual)
Last update posted: Jun 12, 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 12, 2024 · Synced Nov 15, 2026