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NCT03609944 · ClinicalTrials.gov registry record · NA
SpHincterotomy for Acute Recurrent Pancreatitis
A NA study of Pancreatitis and Pancreatitis, Acute, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- NA
- Development phase
- 181
- Enrollment target
- 20
- Study locations
NCT03609944: Completed NA study of Pancreatitis and Pancreatitis, Acute, sponsored by Oregon Health and Science University.
NCT03609944 is a NA study of Pancreatitis and Pancreatitis, Acute that has completed, run by Oregon Health and Science University. The registered enrollment target is 181 participants, below the 611-participant average among 17 other Pancreatitis trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03609944, a NA study of Pancreatitis and Pancreatitis, Acute, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- NA
- Development phase
- 181 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where doctors used a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas. People who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will be will be randomly assigned to either have the ERCP with sphincterotomy procedure, or to have a "sham" procedure. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months.
Primary Outcome
To test this aim, compare the incidence of acute pancreatitis \> 30 days after treatment allocation as the primary outcome measure, using the next attack of acute pancreatitis as a time-to-event outcome.
Conditions Studied
Interventions
- PROCEDURE EUS
- PROCEDURE ERCP with miES
Study Locations (20)
California
- Keck Hospital of USC - Los Angeles
- Cedars-Sinai - Los Angeles
- UCSF Medical Center - San Francisco
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Connecticut
- Yale School of Medicine - New Haven
Georgia
- Emory University Hospital - Atlanta
Illinois
- Northwestern University - Chicago
Indiana
- Indiana University - Indianapolis
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2025-08-31 |
| Phase | NA |
What the finished NCT03609944 record still lists
NCT03609944 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 611-participant average among 17 other Pancreatitis trials with a reported enrollment target (70% lower).
The record links to 5 conditions, with Pancreatitis appearing as the primary indexed condition, and to 2 interventions - of which EUS is the first listed.
NCT03609944 names 20 study sites across 18 states, led by California, Arkansas, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03609944 about?
NCT03609944 is a clinical study titled "SpHincterotomy for Acute Recurrent Pancreatitis". The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where...
What is the current status of trial NCT03609944?
This trial is currently completed. It is a NA study. The enrollment target is 181 participants. The study started on 2018-09-27. Estimated completion is 2025-08-31.
What conditions does trial NCT03609944 study?
This clinical trial studies the following conditions: Pancreatitis, Pancreatitis, Acute, Pancreas Inflamed, Pancreas Divisum, Pancreatitis Idiopathic.
What interventions are being tested in trial NCT03609944?
The interventions under investigation include: EUS (PROCEDURE), ERCP with miES (PROCEDURE).
Who is sponsoring clinical trial NCT03609944?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03609944 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03609944's enrollment target sits among peer trials
181 10th of 17 higher than 8 of 17 other Pancreatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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