title: A novel biodegradable biliary stent in the endoscopic treatment of cystic-duct leakage after cholecystectomy.
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.
  
  
  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.
authors.affiliation: Department of Gastroenterology and Alimentary Tract Surgery, Institute of Biomaterials, Tampere University of Technology, Tampere, and Department of Pathology, Helsinki University Hospital, Helsinki, Finland.
authors.forename: Johanna
authors.initials: J
authors.lastname: Laukkarinen
authors.forename: Isto
authors.initials: I
authors.lastname: Nordback
authors.forename: Joonas
authors.initials: J
authors.lastname: Mikkonen
authors.forename: Päivi
authors.initials: P
authors.lastname: Kärkkäinen
authors.forename: Juhani
authors.initials: J
authors.lastname: Sand
mesh_terms: 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