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Efficacy of an Absorbable Fibrin Sealant Patch (TachoSil) After Distal Pancreatectomy: A Multicenter, Randomized, Controlled Trial

Montorsi, Marco MD*; Zerbi, Alessandro MD*; Bassi, Claudio MD, FACS; Capussotti, Lorenzo MD; Coppola, Roberto MD, FACS§; Sacchi, Matteo MD*the Italian Tachosil Study Group

doi: 10.1097/SLA.0b013e318272dec0
Original Articles From the ESA Proceedings

Objective: To evaluate the role of an absorbable fibrin sealant patch (TachoSil) in reducing postoperative pancreatic fistula (POPF) after distal pancreatectomy (DP).

Background: POPF remains the main complication after DP.

Methods: This was a prospective, open, randomized, study in which patients undergoing elective DP were randomized to standard surgical suturing or stapling with or without TachoSil. The primary end point was the incidence of POPF according to International Study Group on Pancreatic Fistula criteria. Amylase level in drainage fluid, number of days until removal of drain, and duration of hospital stay were secondary end points.

Results: A total of 275 patients were enrolled at 19 centers over a 2-year period (TachoSil, n = 145; standard, n = 130). Twenty percent of procedures were laparoscopic and 21% were spleen-preserving resections. The incidence of POPF was not significantly different between groups (TachoSil, 62%; standard 68%; P = 0.267). Grade A fistula rate was similar in both groups (TachoSil 54%; standard 55%), whereas the grade B + C fistula rate was 8% with TachoSil versus 14% without (P = 0.139). Amylase drainage level on postoperative day 1 was significantly reduced with TachoSil (P = 0.025). Median number of days until drainage removal and length of hospital stay were similar in both groups (7 and 10 days, respectively).

Conclusions: The POPF rate was higher than expected when International Study Group on Pancreatic Fistula criteria were strictly applied, although the majority were biochemical fistulas. TachoSil had no significant effect on the rate of POPF, although there was a significant reduction of amylase level in drainage fluid on postoperative day 1.

Patients undergoing distal pancreatectomy were randomized to standard surgical suturing or stapling with (n = 145) or without (n = 130) TachoSil. The incidence of postoperative pancreatic fistula was not significantly different between groups (TachoSil, 62%; standard 68%; P = 0.267). Amylase level in drainage fluid on postoperative day 1 was reduced with TachoSil P = 0.025).

*Department of General Surgery, University of Milan, Istituto Clinico Humanitas IRCCS, Milano, Italy

Department of Surgery, Università degli Studi di Verona, Policlinico G.B. Rossi, Verona, Italy

Department of Surgery, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy

§Department of Surgery, Università Campus Biomedico, Roma, Italy

Clinical Investigators and Participating Centers List.

Reprints: Marco Montorsi, MD, Department and Chair of General Surgery, University of Milan, Istituto Clinico Humanitas IRCCS, Via Manzoni 56, 20089 Rozzano, Milano, Italy. E-mail: marco.montorsi@humanitas.it.

Disclosure: For monitoring, data management, and statistical analysis related to this research project, funding was provided by Nycomed S.p.A. according to Italian law (D.L. 17 Dec 2004) for an investigator-initiated trial. The authors declare that they have nothing to disclose.

© 2012 Lippincott Williams & Wilkins, Inc.