Recruiting

Viaduct™

Sponsor:

Stanford University

Code:

NCT01818050

Conditions

Bile Duct Stricture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liver Function Tests

Study Details

Brief summary:

Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. 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 WS up to 90 days in 50 patients with biliary obstruction due to stones or benign strictures.

Conditions

Bile Duct Stricture

Study ID

NCT01818050

Start date

Mar, 2013

Status verified date

Apr, 2013

Completion date

Mar, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

  • Expected patient survival of at least 90 days
  • High likelihood of patient follow-up
  • Patient is able to give a written informed consent
  • Patient is willing and able to comply with the study procedures.

Exclusion Criteria:

  • Patients with cholangitis
  • Patients with bile leak
  • Pregnant patients
  • Patients with any contraindication to endoscopic procedure
  • Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
  • Patients with malignant biliary strictures

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Wing stent arm

There is only one arm in this study. Intervention: checking liver function tests to evaluate stent patency

Interventions

Liver Function Tests

LFTs will be checked periodically after Wing stent placement to evaluate stent patency

Primary outcome measure

  • Biliary stent patency [ Time Frame: At 90 days after stent placement ]

Central Contacts and Locations

Locations

Stanford University Hospital

Recruiting

Palo Alto, California, United States, 94035

Contacts

Subhas Banerjee, MD

650-723-2623

Principal Investigator:

Subhas Banerjee, MD

More Information

Sponsor

Stanford University

Last update posted

Apr 8, 2013

Last verified

Apr, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2013-04-08.