Biliary Stricture
Conditions
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.
Interventions
DEVICEWinged biliary stent (ViaDuct™)
Placement of winged biliary stent at ERCP for management of benign biliary stricture.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Stent Patency at 90 Days | 90 days after placement of stent | Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Winged Stent Single arm study (winged biliary stent) | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Winged Stent |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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
Time frame: 90 days after placement of stent
Population: Patients with biliary obstruction (non-malignant) who underwent ERCP with placement of winged biliary stent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Winged Stent | Count of Participants With Stent Patency at 90 Days | 22 Participants |