In vivo evaluation of a new bioabsorbable self-expanding biliary stent.
BACKGROUND
Bioabsorbable stents may offer advantages for the treatment of benign and malignant biliary strictures, including large stent diameter, decreased biofilm accumulation and proliferative changes, elimination of the need for stent removal and imaging artifacts, and prospects for drug impregnation. However, suboptimal expansion has hampered prior iterations. A new bioabsorbable biliary stent (BioStent) was evaluated in a porcine model.


METHODS
BioStents were placed in 8 animals for long-term follow-up. The following were evaluated: accuracy and ease of delivery and deployment, radial expansion, and radiologic visualization. Stent function and biotolerance were assessed by cholangiography, serum bilirubin, and necropsy for histopathology performed in pairs at 2, 4, 6, and 12 months.


RESULTS
Stents were delivered without sphincterotomy and were deployed easily, accurately, and with good immediate stent expansion and radiographic visualization. On follow-up, all stents were fully expanded and serum bilirubin levels remained within the normal range. Although there was no clinical evidence of biliary obstruction, filling defects were common at cholangiography. On histopathologic evaluation, there was neither bile duct integration or proliferative change.


CONCLUSIONS
The BioStent bioabsorbable biliary stent, modified with axial runners, can be effectively deployed endoscopically, is self-expanding, is visualized radiographically, and remains patent up to 6 months. There was no bile duct integration or proliferative change, which are potential advantages. Stent occlusion and migration remain concerns.
Ginsberg
Gregory
G
Gastroenterology Division and Interventional Radiology Division, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA.
Cope
Constantin
C
Shah
Janak
J
Martin
Tanisha
T
Carty
Anthony
A
Habecker
Perry
P
Kaufmann
Carol
C
Clerc
Claude
C
Nuutinen
Juha-Pekka
JP
Törmälä
Pertti
P
D020341:Absorbable Implants; D000818:Animals; D001652:Bile Ducts / Q000473:pathology; D001663:Bilirubin / Q000097:blood; D002758:Cholangiography; D011474:Prosthesis Design; D015607:Stents; D013552:Swine
D001663:Bilirubin