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NCT03333382 · ClinicalTrials.gov registry record · NA
Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks
A NA study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03333382 is a NA study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 1 participants.
The verdict
NCT03333382, a NA study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Standard endoscopic management for anastomotic bile leaks following OLT has been endoscopic retrograde cholangiopancreatography (ERCP) with placement of a temporary plastic biliary endoprosthesis (stent) across the site of anastomotic leak. While this intervention carries a high rate of technical success, clinical success is not universal. An alternative to placement of a plastic biliary stent is placement of a fully covered self-expanding metal stent (FCSEMS). Whereas a plastic stent functions largely as a wick to siphon bile flow, the theoretical advantage of a FCSEMS is that the relatively larger expansile diameter and membrane coating provide an actual and effective seal at the site of leak. FCSEMS have been used successfully for salvage therapy of anastomotic bile leaks in the post-OLT population with no serious stent related adverse events and no cases of unsuccessful FCSEMS removal in this population. The objective of this study is to prospectively randomize patients found to have anastomotic bile leaks following OLT to placement of either a plastic biliary stent or a FCSEMS at initial ERCP intervention.
Interventions
- DEVICE Plastic biliary stent
- DEVICE FCSEMS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-01-30 |
| Est. Completion | 2020-09-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03333382
The ClinicalTrials.gov registry entry for NCT03333382 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Plastic biliary stent is the first listed.
NCT03333382 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03333382 about?
NCT03333382 is a clinical study titled "Plastic vs. Fully Covered Self Expanding Stents (FCSEMS) for Treatment of Anastomotic Bile Leaks". Standard endoscopic management for anastomotic bile leaks following OLT has been endoscopic retrograde cholangiopancreatography (ERCP) with placement of a temporary plastic biliary endoprosthesis (stent) across the site of anastomotic leak. While this intervention carries a high rate of technical su...
What is the current status of trial NCT03333382?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-01-30. Estimated completion is 2020-09-21.
What interventions are being tested in trial NCT03333382?
The interventions under investigation include: Plastic biliary stent (DEVICE), FCSEMS (DEVICE).
Who is sponsoring clinical trial NCT03333382?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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