Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115411
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : April 4, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Subhas Banerjee, Stanford University

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

Condition or disease Intervention/treatment Phase
Biliary Stricture Device: Winged biliary stent (ViaDuct™) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with benign biliary obstruction who meet all inclusion criteria will be approached to consent for placement of a winged biliary stent for 90 days with appropriate laboratory studies and clinical evaluations.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Wing Biliary Stent Patency in Patients With Benign Biliary Obstruction
Actual Study Start Date : September 6, 2011
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : April 10, 2018

Arm Intervention/treatment
Experimental: 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.
Device: Winged biliary stent (ViaDuct™)
Placement of winged biliary stent at ERCP for management of benign biliary stricture.




Primary Outcome Measures :
  1. Count of Participants With Stent Patency at 90 Days [ Time Frame: 90 days after placement of stent ]
    Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115411


Locations
Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
  Study Documents (Full-Text)

Documents provided by Subhas Banerjee, Stanford University:
Layout table for additonal information
Responsible Party: Subhas Banerjee, Associate Professor of Medicine, Division of Gastroenterology, Stanford University
ClinicalTrials.gov Identifier: NCT03115411    
Other Study ID Numbers: IRB 21604
First Posted: April 14, 2017    Key Record Dates
Results First Posted: April 4, 2019
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Constriction, Pathologic
Pathological Conditions, Anatomical