Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction

Biliary Stricture Clinical Trial

Official title:

Prospective Evaluation of Wing Biliary Stent Patency in Patients With Benign Biliary Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115411
• Other study ID #: IRB 21604
• Status: Completed
• Phase: N/A
• Start date: September 6, 2011
• Est. completion date: April 10, 2018

Study information

• Verified date: April 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Expected patient survival of at least 90 days

3. High likelihood of patient follow-up

4. Patient is able to give a written informed consent

5. Patient is willing and able to comply with the study procedures.

Exclusion Criteria:

1. Patients with cholangitis

2. Patients with bile leak

3. Pregnant patients

4. Patients with any contraindication to endoscopic procedure

5. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit

6. Patients with malignant biliary strictures

Related Conditions & MeSH terms

• Biliary Stricture

Intervention

Device:
• Winged biliary stent (ViaDuct™)
Placement of winged biliary stent at ERCP for management of benign biliary stricture.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days after placement of stent