title: Efficacy of an absorbable fibrin sealant patch (TachoSil) after distal pancreatectomy: a multicenter, randomized, controlled trial.
abstract: 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.
authors.affiliation: Department of General Surgery, University of Milan, Istituto Clinico Humanitas IRCCS, Via Manzoni 56, Rozzano, Milan, Italy. marco.montorsi@humanitas.it
authors.forename: Marco
authors.initials: M
authors.lastname: Montorsi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Zerbi
authors.forename: Claudio
authors.initials: C
authors.lastname: Bassi
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Capussotti
authors.forename: Roberto
authors.initials: R
authors.lastname: Coppola
authors.forename: Matteo
authors.initials: M
authors.lastname: Sacchi
mesh_terms: D020341:Absorbable Implants; D016009:Chi-Square Distribution; D004322:Drainage; D004338:Drug Combinations; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy / Q000379:methods*; D010185:Pancreatic Fistula / Q000453:epidemiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D013536:Suture Techniques; D013917:Thrombin / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; C518955:TachoSil; D005340:Fibrinogen; D013917:Thrombin