title: Hemostatic efficacy of TachoSil in liver resection compared with argon beam coagulator treatment: an open, randomized, prospective, multicenter, parallel-group trial.
abstract: BACKGROUND
  The aim of this trial was to confirm previous results demonstrating the efficacy and safety of a fixed combination tissue sealant versus argon beam coagulation (ABC) treatment in liver resection.
  
  
  METHODS
  This trial was designed as an international, multicenter, randomized, controlled surgical trial with 2 parallel groups. Patients were eligible for intra-operative randomization after elective resection of ≥ 1 liver segment and primary hemostasis. The primary end point was the time to hemostasis after starting the randomized intervention to obtain secondary hemostasis. Secondary end points were drainage duration, volume, and content. Adverse events were collected to evaluate the safety of treatments. The trial was registered internationally (Eudract number 2008-006407-23).
  
  
  RESULTS
  Among 119 patients (60 TachoSil and 59 ABC) randomized in 10 tertiary care centers in Europe, the mean time to hemostasis was less when TachoSil was used (3.6 minutes) compared with ABC (5.0 minutes; P = .0018). The estimated ratio of mean time to hemostasis for TachoSil/ABC was 0.61 (95% confidence interval, 0.47-0.80; P = .0003). Postoperative drainage volume, drainage fluid, and drainage duration did not differ between the 2 groups. Mortality (2 vs 4 patients) and adverse reactions (24 vs 28 patients) for TachoSil versus ABC did not differ.
  
  
  CONCLUSIONS
  This trial confirmed that TachoSil achieved significantly faster hemostasis after liver resection compared with ABC. Postoperative morbidity and mortality remained unchanged between both groups.
authors.affiliation: Department of Surgery, University of Heidelberg, Heidelberg, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Fischer
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Seiler
authors.forename: Christoph E
authors.initials: CE
authors.lastname: Broelsch
authors.forename: Bernard
authors.initials: B
authors.lastname: de Hemptinne
authors.forename: Jürgen
authors.initials: J
authors.lastname: Klempnauer
authors.forename: Hans-Jörg
authors.initials: HJ
authors.lastname: Mischinger
authors.forename: Heinz-Jochen
authors.initials: HJ
authors.lastname: Gassel
authors.forename: Mogens
authors.initials: M
authors.lastname: Rokkjaer
authors.forename: Rolf
authors.initials: R
authors.lastname: Schauer
authors.forename: Peter N
authors.initials: PN
authors.lastname: Larsen
authors.forename: Vilhelm
authors.initials: V
authors.lastname: Tetens
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
mesh_terms: D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control; D016001:Confidence Intervals; D004338:Drug Combinations; D005060:Europe; D005260:Female; D005340:Fibrinogen; D005500:Follow-Up Studies; D006488:Hemostasis, Surgical / Q000379:methods; D006490:Hemostatics / Q000627:therapeutic use; D006498:Hepatectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007430:Intraoperative Care / Q000379:methods; D053208:Kaplan-Meier Estimate; D017075:Laser Coagulation / Q000379:methods*; D054020:Lasers, Gas / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D011446:Prospective Studies; D012107:Research Design; D018570:Risk Assessment; D016037:Single-Blind Method; D015996:Survival Rate; D013917:Thrombin; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D006490:Hemostatics; C518955:TachoSil; D014014:Tissue Adhesives; D005340:Fibrinogen; D013917:Thrombin