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.

Study design: 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.