Johanna Laukkarinen1, Isto Nordback, Joonas Mikkonen, Päivi Kärkkäinen, Juhani Sand. 1. Department of Gastroenterology and Alimentary Tract Surgery, Institute of Biomaterials, Tampere University of Technology, Tampere, and Department of Pathology, Helsinki University Hospital, Helsinki, Finland.
Abstract
BACKGROUND: A bile leak is a common complication after a cholecystectomy. OBJECTIVE: The 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. DESIGN: Prospective animal study. SETTING: After 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 MEASUREMENTS: The 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. RESULTS: In 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. CONCLUSIONS: This 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.
BACKGROUND: A bile leak is a common complication after a cholecystectomy. OBJECTIVE: The 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. DESIGN: Prospective animal study. SETTING: After 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 MEASUREMENTS: The 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. RESULTS: In 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. CONCLUSIONS: This 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.
Authors: A Repici; N Pagano; G Rando; A Carlino; E Vitetta; E Ferrara; G Strangio; A Zullo; C Hassan Journal: Surg Endosc Date: 2013-02-27 Impact factor: 4.584