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

Not Applicable

Completed

• Conditions: Biliary Stricture
• Interventions: Device: Winged biliary stent (ViaDuct™)

• Registration Number: NCT03115411
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-09-06
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-14
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Results First Submitted: 2019-03-08
• Results First Submitted QC: 2019-03-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Results First Posted: 2019-04-04
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Winged stent	Winged biliary stent (ViaDuct™)	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.

Primary Outcome Measures

Name	Time	Method
Count of Participants With Stent Patency at 90 Days	90 days after placement of stent	Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States