Bile Duct Stricture Clinical Trial
Official title:
Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™)
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.
1. Fifty patients that meet all the inclusion criteria and have none of the exclusion
criteria will be invited to participate in the study.
2. Initial visit:
- Written informed consent will be obtained
- Complete history and physical will be performed and the patients baseline liver
function tests and imaging results will be assessed and noted in the case report
form.
- Patients gender, date of birth, concomitant medications will be noted.
3. Procedure:
Patients will then be scheduled for the ERCP procedure with wing biliary stent
placement. They will undergo the ERCP as standard of care and the wing biliary stent
will be placed for decompression of the obstructed biliary system in situations where
stenting is standard of care. 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.
4. Bloodwork:
Patients will undergo bloodwork (total and direct bilirubin, alanine aminotransferase,
aspartate aminotransferase, alkaline phosphatase) one week after the procedure. The
degree of drop in bilirubin will also be noted. The patients will be then have these
labs drawn again at 4, 8 and 12 weeks after the procedure.
5. Telephone calls:
The patients will be called on the telephone at weeks 2, 4, 6, 8, 10 after the
procedure to monitor their clinical status. Patients and family members will be given a
contact number to call us immediately if they develop any signs of biliary obstruction
such as fever, abdominal pain, jaundice, dark urine or light stools. They will also be
instructed to come to the emergency room should they develop fevers.
6. Stent removal:
At the end of 90 days from the stent placement patients will return for a repeat ERCP
for stent removal as the standard of care and further endo-therapy as indicated.
7. Stent patency will be calculated from the time of stent insertion up to the end of 90
days. The stent patency rate at 90 days will be the proportion of stents placed that do
not occlude over this time period. Stent occlusion will be defined as biochemical or
clinical evidence of obstructive jaundice.
8. All the continuous and outcome variables (stent obstruction) will be statistically
analyzed and stent malfunction rates will be analyzed for the wing stent across the
various indications.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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