Stump closure reinforcement with absorbable fibrin collagen sealant sponge (TachoSil) does not prevent pancreatic fistula after distal pancreatectomy: the FIABLE multicenter controlled randomized study

• Published in: The American journal of surgery 2015-10, Vol.210 (4), p.739-748
• Main Authors: Sa Cunha, Antonio, M.D., Ph.D, Carrere, Nicolas, M.D., Ph.D, Meunier, Bernard, M.D., Ph.D, Fabre, Jean-Michel, M.D, Sauvanet, Alain, M.D, Pessaux, Patrick, M.D., Ph.D, Ortega-Deballon, Pablo, M.D., Ph.D, Fingerhut, Abe, M.D, Lacaine, François, M.D., Ph.D
• Format: Article
• Language: English
• Subjects: Abdomen; Adult; Aged; Aged, 80 and over; Collagen; Distal pancreatectomy; Double-Blind Method; Drug Combinations; Female; Fibrinogen - therapeutic use; Hospitalization; Humans; Laparoscopy; Life Sciences; Male; Middle Aged; Mortality; Multicenter controlled randomized study; Pancreas; Pancreatectomy - adverse effects; Pancreatic Diseases - complications; Pancreatic Diseases - pathology; Pancreatic Diseases - surgery; Pancreatic Fistula - etiology; Pancreatic Fistula - prevention & control; Postoperative pancreatic fistula; Prevention; Reinforcement; Stump closure; Surgery; Suture Techniques; Thrombin - therapeutic use; Treatment Outcome; Young Adult
• ISSN: 0002-9610; 1879-1883
• DOI: 10.1016/j.amjsurg.2015.04.015

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. Conclusion TachoSil sponge reinforcement of the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF.