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NCT01221311 · ClinicalTrials.gov registry record · NA
Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 112
- Enrollment target
NCT01221311: Completed NA study, sponsored by Medical University of South Carolina.
NCT01221311 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 112 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01221311, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
Study Summary
The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.
Primary Outcome
Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.
Interventions
- DEVICE Fully covered Metallic Stent
- DEVICE Plastic Stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-10 |
| Phase | NA |
What the finished NCT01221311 record still lists
NCT01221311 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Fully covered Metallic Stent is the first listed.
NCT01221311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01221311 about?
NCT01221311 is a clinical study titled "Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures". The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adeq...
What is the current status of trial NCT01221311?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2011-01. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01221311?
The interventions under investigation include: Fully covered Metallic Stent (DEVICE), Plastic Stent (DEVICE).
Who is sponsoring clinical trial NCT01221311?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01221311's enrollment target sits among peer trials
112 813th of 2000 higher than 1,185 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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