Stump closure reinforcement with absorbable fibrin collagen sealant sponge (TachoSil) does not prevent pancreatic fistula after distal pancreatectomy: the FIABLE multicenter controlled randomized study - 16/09/15
, François Lacaine, M.D., Ph.D. iFrench Fédération de Recherche EN Chirurgie (FRENCH)
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.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Several procedures have been proposed to reduce the rate and/or severity of POPF. |
• | This multicenter controlled randomized trial evaluated the usefulness of TachoSil sponge on remnant stump in reducing the rate and severity of POPF. |
• | TachoSil sponge on the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF. |
• | Hand-sewn pancreatic remnant closure and splenic vessel ligation in splenic preservation were independent predictive factors for the onset of clinically patent POPF. |
• | Negative studies must be published to avoid publication and reporting bias before drawing methodologically sound conclusions as to the usefulness or futility of therapeutic decisions. |
Keywords : Stump closure, Reinforcement, Prevention, Postoperative pancreatic fistula, Distal pancreatectomy, Multicenter controlled randomized study
Plan
| FIABLE: Efficacité sur la survenue des FIstules pAncréatiques et la tolérance de l’éponge de TachoSil appliquée sur la tranche de section pancréatique chez les patients ayant suBi une pancréatectomie distaLE pour tumeur. |
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| This study was approved by the Committee for the Protection of Patients under the number CPP 08012, and registered with the European Clinical Trials Database EUDRACT under the number 2008-001253-17. |
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| Nycomed supported the performance of this study. |
|
| The authors declare no conflicts of interest. |
Vol 210 - N° 4
P. 739-748 - octobre 2015 Retour au numéro
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