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NCT01815619 · ClinicalTrials.gov registry record · NA
Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct
A NA study, sponsored by AdventHealth.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT01815619: Completed NA study, sponsored by AdventHealth.
NCT01815619 is a NA study that has completed, run by AdventHealth. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815619, a NA study, has completed, sponsored by AdventHealth.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study will test two different methods for processing biopsy specimens taken from the bile duct. Patient;s who are asked to participate int his study have a stricture in the bile duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde cholangiopancreatography (ERCP) so that a diagnosis can be made. Standard of care includes performing single operator cholangioscopy-guided biopsies in the bile duct and sending the tissue to the lab for testing to make a diagnosis. Using this method the investigators can establish a diagnosis only about 50% of the time. The investigators believe that if a cytopathologist is available in the endoscopy suite during the procedure to evaluate the biopsy specimens onsite, the investigators can improve the diagnostic accuracy. The purpose of this study is to compare two methods for processing biopsies obtained from the bile duct (Onsite vs. Offsite).
Primary Outcome
The primary endpoint of the study is to compare the diagnostic accuracy rates between two different methods used for processing specimens obtained from the bile duct.
Interventions
- OTHER on-site specimen evaluation
- OTHER off-site specimen evaluation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-02 |
| Est. Completion | 2020-08-25 |
| Phase | NA |
What the finished NCT01815619 record still lists
NCT01815619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which on-site specimen evaluation is the first listed.
NCT01815619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01815619 about?
NCT01815619 is a clinical study titled "Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct". This study will test two different methods for processing biopsy specimens taken from the bile duct. Patient;s who are asked to participate int his study have a stricture in the bile duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde cholangiopancreatograph...
What is the current status of trial NCT01815619?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2013-02. Estimated completion is 2020-08-25.
What interventions are being tested in trial NCT01815619?
The interventions under investigation include: on-site specimen evaluation (OTHER), off-site specimen evaluation (OTHER).
Who is sponsoring clinical trial NCT01815619?
This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01815619's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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