An interventional study of Winged biliary stent (ViaDuct™) in Biliary Stricture, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.
ERCP with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent obstruction is a major limitation of this approach. Studies have shown that the conventional tubular type polyethylene stents (CS) with side holes accumulate significant sludge and their mean patency is approximately 90 days.
Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3 months.
Recently, a stent with a star-shaped cross-section has been developed for biliary applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent.
The stent which is star shaped in cross section, channels fluid along its winged perimeter.
It has been proposed that the winged stent design with a lack of central lumen obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of multiple external drainage channels, is smaller. Longer term biliary drainage without the need for stent exchange should therefore be possible with these stents.
The primary aim of this study is to prospectively evaluate the patency rate of the winged stent in up to 90 days for patients with benign biliary obstruction.
Stanford University is the lead sponsor of 2,162 studies on the registry; 429 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.
One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
Exclusion Criteria:
Placement of Winged stent for management of biliary obstruction. Stent to be placed for 90 days, with laboratory studies and clinical evaluation during this period to assess for stent potency.
Device: Winged biliary stent (ViaDuct™)
Placement of winged biliary stent at ERCP for management of benign biliary stricture.
Count of Participants With Stent Patency at 90 Days
Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction
Time frame: 90 days after placement of stent
| Milestone | Winged Biliary Stent |
|---|---|
| Started | 23 |
| Completed | 23 |
| Not completed | 0 |
Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction
| Participants | Winged Stent |
|---|---|
| Count of Participants With Stent Patency at 90 Days | 22 |
Collected over 90 day stent potency was assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Winged Stent | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | Winged Stent |
|---|---|
| Mean | 55 ± 12 |
| Sex: Female, Male(Participants) | Winged Stent |
|---|---|
| Female | 8 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | Winged Stent |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 12 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Winged Stent |
|---|---|
| United States | 23 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2011 to primary completion in Apr 2018, 79 months.
Results were first posted in Apr 2019, 11 months after primary completion.
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