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

Shogo Kobayashi, Yutaka Takeda, Shin Nakahira, Masanori Tsujie, Junzo Shimizu, Atsushi Miyamoto, Hidetoshi Eguchi, Hiroaki Nagano, Yuichiro Doki, Masaki Mori

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)59-64
Number of pages6
JournalJournal of the American College of Surgeons
Volume222
Issue number1
DOIs
Publication statusPublished - Jan 1 2016
Externally publishedYes

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Polyglycolic Acid
Fibrin Tissue Adhesive
Bile
Fibrinogen
Collagen
Hemorrhage
Liver
Paracentesis
Morbidity
Surgical Wound Infection
Jaundice
Hemostasis
Bilirubin
Randomized Controlled Trials
Retrospective Studies

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

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. / Kobayashi, Shogo; Takeda, Yutaka; Nakahira, Shin; Tsujie, Masanori; Shimizu, Junzo; Miyamoto, Atsushi; Eguchi, Hidetoshi; Nagano, Hiroaki; Doki, Yuichiro; Mori, Masaki.

In: Journal of the American College of Surgeons, Vol. 222, No. 1, 01.01.2016, p. 59-64.

Research output: Contribution to journalArticle

Kobayashi, Shogo ; Takeda, Yutaka ; Nakahira, Shin ; Tsujie, Masanori ; Shimizu, Junzo ; Miyamoto, Atsushi ; Eguchi, Hidetoshi ; Nagano, Hiroaki ; Doki, Yuichiro ; Mori, Masaki. / 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. In: Journal of the American College of Surgeons. 2016 ; Vol. 222, No. 1. pp. 59-64.
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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.",
author = "Shogo Kobayashi and Yutaka Takeda and Shin Nakahira and Masanori Tsujie and Junzo Shimizu and Atsushi Miyamoto and Hidetoshi Eguchi and Hiroaki Nagano and Yuichiro Doki and Masaki Mori",
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T1 - Fibrin Sealant with Polyglycolic Acid Felt vs Fibrinogen-Based Collagen Fleece at the Liver Cut Surface for Prevention of Postoperative Bile Leakage and Hemorrhage

T2 - A Prospective, Randomized, Controlled Study

AU - Kobayashi, Shogo

AU - Takeda, Yutaka

AU - Nakahira, Shin

AU - Tsujie, Masanori

AU - Shimizu, Junzo

AU - Miyamoto, Atsushi

AU - Eguchi, Hidetoshi

AU - Nagano, Hiroaki

AU - Doki, Yuichiro

AU - Mori, Masaki

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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.

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