Small intestinal submucosa as a bioscaffold for biliary tract regeneration.

BACKGROUND Porcine small intestinal submucosa (SIS) biograft is used as a bioscaffold for regeneration of a variety of tissues. To date, SIS has not been used as a biliary tract graft. The purpose of this study was to evaluate the feasibility of using SIS as a scaffold for bile duct tissue regeneration in a canine model. METHODS Fifteen, 25- to 35-kg mongrel dogs underwent midline laparotomy and exposure of the common bile duct. Nine dogs had a longitudinal choledochotomy and a 2- x 1-cm elliptical patch of 4-ply SIS placed using 6-0 polypropylene suture. Six dogs had the anterior two thirds of the bile duct resected and a 2- to 3-cm tubularized 4-ply SIS interposition graft placed. Dogs were killed at intervals ranging from 2 weeks to 5 months. Before killing, liver function tests (alkaline phosphatase [U/L] and total bilirubin [mg/dL]) were evaluated, cholangiograms were performed, and the bile duct was examined histologically. RESULTS Fourteen out of 15 dogs survived and were healthy at the time of killing. The one failure was a result of a bile leak in a patched animal. The SIS showed signs of incorporation with infiltration of native fibroblasts, blood vessels, and biliary mucosa within 2 weeks. Within 3 months the SIS graft was replaced with native collagen covered with a biliary epithelium. No changes occurred at 5-month follow-up. One animal with an interposition graft developed a stricture at the proximal anastomosis within 2 months. In the remaining dogs, liver enzymes were normal, and the caliber of the common bile duct remained normal. CONCLUSIONS SIS can be used for regeneration of bile duct tissue in a canine model. In 13 of 15 dogs SIS resulted in regeneration of canine common bile duct when used as a patch or as an interposition graft. The potential for the use of SIS as a patch for biliary stricturoplasty, or as an interposition graft for repair of complex biliary injuries is encouraging.