Fischer, Lars2; Seiler, Christoph M.2; Broelsch, Christoph E.3; Hemptinne, Bernard de4; Klempnauer, Jürgen5; Mischinger, Hans -Jörg6; Gassel, Heinz-Jochen7; Rokkjær, Mogens1; Schauer, Rolf8; Larsen, Peter N.9; Tetens, Vilhelm10; Büchler, Markus W.2
1 The Department of Surgical Gastroenterology L, Faculty of Health Sciences, Aarhus University, Aarhus University2 Department of Surgery, University of Heidelberg, Heidelberg3 Department of General and Transplantation Surgery, University of Essen, Essen4 Department of Surgery, University Hospital of Ghent, Ghent5 Department of Visceral and Transplantation Surgery, Medical University of Hannover, Hannover6 Department of Surgery, University Medical Center, Graz7 Department of Surgery, Evangelic Hospital, Mülheim a.d. Ruhr8 Department of Surgery, University Hospital of Munich, , Grosshadern9 Clinic of Surgical Gastroenterology, Copenhagen University Hospital, Copenhagen10 Medical Scientific Strategy and Medical Marketing, Nycomed Group, Roskilde
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 secondaty 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 ws 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. Conclusion: This trial confirmed that TachoSil achieved significantly faster hemostasis after liver resection compared with ABC. Postoperative morbidity and mortality remained unchanged between both groups.