A novel biodegradable biliary stent in the endoscopic treatment of cystic-duct leakage after cholecystectomy

BackgroundA bile leak is a common complication after a cholecystectomy.ObjectiveThe use of a novel, self-expanding, radiopaque polylactide–barium sulphate biodegradable stent and a polyethylene stent was investigated in 12 pigs with cystic-duct leakage.DesignProspective animal study.SettingAfter cholecystectomy, the cystic duct was left without ligation, and then the foramen of Winslow was drained extra-abdominally. During the duodenoscopy, a biodegradable or a polyethylene biliary stent was inserted into the bile duct.Main Outcome MeasurementsThe bile-drain output was measured daily, and when it was below 20 mL/d, the drain was removed. The animals were followed by repeated abdominal radiographs and serum determinations until they were euthanized at 6 months, when histologic evaluation of the bile duct and surrounding tissues was performed.ResultsIn the biodegradable stent group, the total external output of bile was significantly smaller (median [range], 165 mL [100-1740 mL] vs 710 mL [355-1020 mL]; P < .01) and the drains could be removed earlier (5 days [4-5 days] vs 7 days [6-7 days] after surgery; P < .05) compared with the plastic stent group. In the abdominal radiograph, a biodegradable or polyethylene stent was seen to be in place in all animals at 3 months and in 0 of 6 (biodegradable biliary stent group) and 1 of 5 (polyethylene biliary stent group) animals at 6 months. One polyethylene stent was found to be clotted at the necropsy at 6 months. The rest of the stents had disappeared by 6 months, and there was no significant difference in the bile-duct inner diameter or the histology between the groups.ConclusionsThis novel biodegradable stent is applicable, safe, and effective in the endoscopic treatment of postcholecystectomy cystic-duct leakage. In addition, the subsequent removal of the stent can be avoided. These encouraging experimental results warrant further clinical trials.