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


METHODS
Prospective animal study.


METHODS
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.


METHODS
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.
Laukkarinen
Johanna
J
Department of Gastroenterology and Alimentary Tract Surgery, Institute of Biomaterials, Tampere University of Technology, Tampere, and Department of Pathology, Helsinki University Hospital, Helsinki, Finland.
Nordback
Isto
I
Mikkonen
Joonas
J
Kärkkäinen
Päivi
P
Sand
Juhani
J
D020341:Absorbable Implants; D000818:Animals; D001660:Biliary Tract Diseases / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D002763:Cholecystectomy / Q000009:adverse effects*; D003549:Cystic Duct / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D004195:Disease Models, Animal; D004384:Duodenoscopy / Q000379:methods*; D005500:Follow-Up Studies; D011183:Postoperative Complications; D011446:Prospective Studies; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000295:instrumentation*; D011859:Radiography; D015607:Stents; D013552:Swine; D016896:Treatment Outcome