Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™)

NCT01818050 | Unknown Phase 4 DMC

• 1 other identifier: 21604
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. 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 WS up to 90 days in 50 patients with biliary obstruction due to stones or benign strictures.

Conditions

Bile Duct Stricture

Outcome Measures

Primary Outcomes (1)

• Biliary stent patency

  At 90 days after stent placement

Secondary Outcomes (1)

• Liver Function Test improvement

  90 days

Study Arms (1)

Wing stent arm

OTHER

There is only one arm in this study. Intervention: checking liver function tests to evaluate stent patency

Other: Liver Function Tests

Interventions

Liver Function Tests OTHER

LFTs will be checked periodically after Wing stent placement to evaluate stent patency

Wing stent arm

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
• GI Supply: collaborator

Study Sites (1)

Stanford University Hospital

Palo Alto, California, 94035, United States

RECRUITING

Related Publications (1)

• Schmidt A, Riecken B, Rische S, Klinger C, Jakobs R, Bechtler M, Kahler G, Dormann A, Caca K. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study. Endoscopy. 2015 May;47(5):430-6. doi: 10.1055/s-0034-1391232. Epub 2015 Jan 15.

  PMID: 25590188 DERIVED

Study Officials

• Subhas Banerjee

  Stanford University

  PRINCIPAL INVESTIGATOR

• Rajan Kochar, MD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

US (1)