Antonio Sa Cunha1, Nicolas Carrere2, Bernard Meunier3, Jean-Michel Fabre4, Alain Sauvanet5, Patrick Pessaux6, Pablo Ortega-Deballon7, Abe Fingerhut8, François Lacaine9. 1. Service de Chirurgie Hépato-biliare, Centre Hépato-Biliaire, Hôpital Paul Brousse, Villejuif, France. 2. Service de Chirurgie Générale et Digestive, Hôpital Purpan, Toulouse, France. 3. Service de Chirurgie Hépato-Biliaire et Digestive, Hôpital Pontchaillou, Rennes, France. 4. Service de Chirurgie Digestive A, Hôpital St Eloi, Montpellier, France. 5. Service de Chirurgie Hépato-Bilio-Pancréatique, Hôpital Beaujon, Clichy, France. 6. Service de Chirurgie Hépato-Bilio-Pancréatique, Hôpital Hautepierre, Strasbourg, France. 7. Service de Chirurgie Digestive et Cancérologique, Hôpital du Bocage, Dijon, France. 8. Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria. Electronic address: abefingerhut@aol.com. 9. Service de Chirurgie Digestive et Viscérale, Hôpital Tenon, Paris, France.
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.
RCT Entities:
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.
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