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NCT02476279 · ClinicalTrials.gov registry record · Phase 3
Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis
A Phase 3 study of Post-ERCP Pancreatitis, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,950
- Enrollment target
- 20
- Study locations
NCT02476279 is a Phase 3 study of Post-ERCP Pancreatitis that has completed, run by Medical University of South Carolina. The registered enrollment target is 1,950 participants. The trial reports 20 study locations across 18 states.
The verdict
NCT02476279, a Phase 3 study of Post-ERCP Pancreatitis, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,950 participants
- Enrollment target
- 20
- Study locations
Study 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
Conditions Studied
Interventions
- 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 Locations (20)
Ohio
- Case Western Reserve University - Cleveland
- The Ohio State University Wexner Medical Center - Columbus
Other
- University of Calgary - Calgary
- McGill University - Montreal
California
- Univesrity of Southern California - Los Angeles
Colorado
- University of Colorado - Denver
Florida
- The Florida Hospital - Orlando
Georgia
- Emory University - Atlanta
Illinois
- Northwestern University - Chicago
Kansas
- University of Kansas - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,950 participants |
| Start Date | 2015-09 |
| Est. Completion | 2023-01-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02476279
The ClinicalTrials.gov registry entry for NCT02476279 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,950 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post-ERCP Pancreatitis appearing as the primary indexed condition, and to 2 interventions - of which Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement is the first listed.
NCT02476279 reports 20 study locations spanning 18 distinct geographic areas - top geographies include Ohio, Other, California.
Frequently Asked Questions
What is clinical trial NCT02476279 about?
NCT02476279 is a clinical study titled "Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis". 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...
What is the current status of trial NCT02476279?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,950 participants. The study started on 2015-09. Estimated completion is 2023-01-25.
What conditions does trial NCT02476279 study?
This clinical trial studies the following conditions: Post-ERCP Pancreatitis.
What interventions are being tested in trial NCT02476279?
The interventions under investigation include: 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 (OTHER).
Who is sponsoring clinical trial NCT02476279?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02476279 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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