Trial Outcomes & Findings for Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction (NCT NCT03115411)

Last Updated: 2019-04-16

Results Overview

Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

90 days after placement of stent

Results posted on

2019-04-16

Participant milestones
Measure	Winged Biliary Stent Typical biliary stents have a circular, straw-like lumen. Recently, a stent with a star-shaped cross-section and no central lumen 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. in this arm, we utilize the biliary wing stent in standard clinical settings (biliary obstruction) and assess patency
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Winged Stent n=23 Participants Single arm study (winged biliary stent)
Age, Continuous	55 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

Timeframe: 90 days after placement of stent

Population: Patients with biliary obstruction (non-malignant) who underwent ERCP with placement of winged biliary stent.

Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction

Outcome measures
Measure	Winged Stent n=23 Participants Single arm study (winged biliary stent)
Count of Participants With Stent Patency at 90 Days	22 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Stanford University School of Medicine

Phone: 650-723-2623