title: Stump closure reinforcement with absorbable fibrin collagen sealant sponge (TachoSil) does not prevent pancreatic fistula after distal pancreatectomy: the FIABLE multicenter controlled randomized study.
abstract: BACKGROUND
  The aim of this study is to evaluate the effectiveness of TachoSil sponge on distal pancreatectomy remnant stump in reducing the rate and severity of postoperative pancreatic fistula (POPF).
  
  
  METHODS
  All consecutive patients requiring distal pancreatectomy were randomized in 45 centers. The principal end point was onset of "clinically relevant" POPF. Univariate and multivariate analyses were searched for predictive factors.
  
  
  RESULTS
  Of the 270 patients randomized (134 with TachoSil; 136 without), 150 (55.6%) patients sustained a POPF [74 clinically relevant and 76 clinically silent (27.4% and 28.1%), respectively]: no statistically significant difference was found between patients sustaining clinically relevant POPF [41 (30.6%) with vs 33 (24.3%) without TachoSil (P = .276)], or overall POPF [73 (54.5%) with vs 77 (56.6%) without TachoSil, (P = .807)], but there were more clinically relevant POPF after hand-sewn (32.3%) versus mechanical closure (19.8%) (P = .025) and, in case of splenic preservation, after splenic vessel ligation (15/32, 46.9%) versus vascular preservation (17/72, 23.6%) (P = .024). Hand-sewn pancreatic remnant closure (P = .023) and splenic vessel ligation in splenic preservation (P = .035) were independent predictive factors for the onset of clinically relevant POPF.
  
  
  CONCLUSIONS
  TachoSil sponge reinforcement of the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF.
authors.affiliation: Service de Chirurgie Hépato-biliare, Centre Hépato-Biliaire, Hôpital Paul Brousse, Villejuif, France.
authors.forename: Antonio
authors.initials: A
authors.lastname: Sa Cunha
authors.affiliation: Service de Chirurgie Générale et Digestive, Hôpital Purpan, Toulouse, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Carrere
authors.affiliation: Service de Chirurgie Hépato-Biliaire et Digestive, Hôpital Pontchaillou, Rennes, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Meunier
authors.affiliation: Service de Chirurgie Digestive A, Hôpital St Eloi, Montpellier, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Fabre
authors.affiliation: Service de Chirurgie Hépato-Bilio-Pancréatique, Hôpital Beaujon, Clichy, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Sauvanet
authors.affiliation: Service de Chirurgie Hépato-Bilio-Pancréatique, Hôpital Hautepierre, Strasbourg, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Pessaux
authors.affiliation: Service de Chirurgie Digestive et Cancérologique, Hôpital du Bocage, Dijon, France.
authors.forename: Pablo
authors.initials: P
authors.lastname: Ortega-Deballon
authors.affiliation: Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria. Electronic address: abefingerhut@aol.com.
authors.forename: Abe
authors.initials: A
authors.lastname: Fingerhut
authors.affiliation: Service de Chirurgie Digestive et Viscérale, Hôpital Tenon, Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Lacaine
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy / Q000009:adverse effects*; D010182:Pancreatic Diseases / Q000150:complications / Q000473:pathology / Q000601:surgery*; D010185:Pancreatic Fistula / Q000209:etiology / Q000517:prevention & control*; D013536:Suture Techniques; D013917:Thrombin / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C518955:TachoSil; D005340:Fibrinogen; D013917:Thrombin
keywords: Distal pancreatectomy; Multicenter controlled randomized study; Postoperative pancreatic fistula; Prevention; Reinforcement; Stump closure