title: Fibrin Sealant with Polyglycolic Acid Felt vs Fibrinogen-Based Collagen Fleece at the Liver Cut Surface for Prevention of Postoperative Bile Leakage and Hemorrhage: A Prospective, Randomized, Controlled Study.
abstract: BACKGROUND
  The incidence of postoperative biliary leakage and hemorrhage is low, but these factors remain important in liver surgery, and this study's objective was to explore the efficacy of fibrin sealant (FS) with polyglycolic acid (PGA) vs fibrinogen-based collagen fleece (CF) at the liver cut surface. Fibrinogen-based collagen fleece is generally used for hemostasis; PGA-FS has reduced biliary leakage in several retrospective studies.
  
  
  METHODS
  We designed a multicenter, randomized, controlled trial. The primary outcome was the rate of biliary leakage and hemorrhage. Secondary outcomes included morbidities and effusion at the liver cut surface at 3 months post-surgery. Biliary leakage was diagnosed when the drain/serum bilirubin ratio was >5. Hemorrhage was diagnosed when relaparotomy or transfusion was needed.
  
  
  RESULTS
  Of 786 patients from 11 institutions enrolled from 2009 to 2014, a total of 391 were randomly assigned to PGA-FS and 395 to CF. Regarding primary outcomes, rates of biliary leakage were 4.1% with PGA-FS and 5.1% with CF, and rates of hemorrhage were 1.0% in each group; groups did not differ significantly. For secondary outcomes, morbidity rates were 18.7% in the PGA-FS group and 24.6% in the CF group (p = 0.0450). Effusion at the cut liver surface was less with PGA-FS (22.2%) than with CF (32.9%) (p = 0.0142). Regarding morbidity, infection around the liver, jaundice, and abdominal paracentesis were less in the PGA-FS group.
  
  
  CONCLUSIONS
  Compared with CF, PGA-FS did not reduce biliary leakage and hemorrhage. Surgical site infection around the liver, effusion at the liver cut surface, and abdominal paracentesis were less in the PGA-FS group.
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan; Department of Surgery, Osaka University Hospital, Osaka, Japan. Electronic address: s-kobayashi@umin.ac.jp.
authors.forename: Shogo
authors.initials: S
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Osaka, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takeda
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Osaka, Japan.
authors.forename: Shin
authors.initials: S
authors.lastname: Nakahira
authors.affiliation: Department of Surgery, Nara Hospital, Kinki University Faculty of Medicine, Osaka, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Tsujie
authors.affiliation: Department of Surgery, Osaka Rosai Hospital, Osaka, Japan.
authors.forename: Junzo
authors.initials: J
authors.lastname: Shimizu
authors.affiliation: Department of Hepatobiliary-Pancreatic Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Miyamoto
authors.affiliation: Department of Surgery, Osaka University Hospital, Osaka, Japan.
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Eguchi
authors.affiliation: Department of Surgery, Osaka University Hospital, Osaka, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nagano
authors.affiliation: Department of Surgery, Osaka University Hospital, Osaka, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
authors.affiliation: Department of Surgery, Osaka University Hospital, Osaka, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
mesh_terms: D000328:Adult; D000368:Aged; D001646:Bile; D001649:Bile Duct Diseases / Q000209:etiology / Q000517:prevention & control; D003094:Collagen / Q000627:therapeutic use*; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D005340:Fibrinogen / Q000627:therapeutic use*; D006498:Hepatectomy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011100:Polyglycolic Acid / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D019106:Postoperative Hemorrhage / Q000517:prevention & control; D011446:Prospective Studies; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D015718:Fibrin Tissue Adhesive; D014014:Tissue Adhesives; D011100:Polyglycolic Acid; D005340:Fibrinogen; D003094:Collagen