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

NCT03115411 | Completed Results FDA Device

• 1 other identifier: IRB 21604
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Stricture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Winged stent

EXPERIMENTAL

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™)

Interventions

Winged biliary stent (ViaDuct™) DEVICE

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

Winged stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Limitations and Caveats

Small sample size.

Results Point of Contact

• Title: Dr. Subhas Banerjee, MD
• Organization: Stanford University School of Medicine

sbanerje@stanford.edu

650-723-2623

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Gastroenterology

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 14, 2017
• Study Start: September 6, 2011
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: April 16, 2019
• Results First Posted: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)