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

NCT ID: NCT03115411

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-06
• Study Completion Date: 2018-04-10

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.

Conditions

Biliary Stricture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Winged stent

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.

Group Type: EXPERIMENTAL

Winged biliary stent (ViaDuct™)

Intervention Type: DEVICE

Placement of winged biliary stent at ERCP for management of benign biliary stricture.

Interventions

Winged biliary stent (ViaDuct™)

Placement of winged biliary stent at ERCP for management of benign biliary stricture.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Subhas Banerjee

Associate Professor of Medicine, Division of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB 21604

Identifier Type: -

Identifier Source: org_study_id