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

American Journal of Surgery

Volumn 210, Issue 4, 2015, Pages 739-748

  Sa Cunha, Antonio ^a   Carrere, Nicolas ^b   Meunier, Bernard ^c   Fabre, Jean Michel ^d   Sauvanet, Alain ^e   Pessaux, Patrick ^f   Ortega Deballon, Pablo ^g   Fingerhut, Abe ^h   Lacaine, François ⁱ  

^a HÔPITAL PAUL BROUSSE   (France)

^b CHU PURPAN   (France)

^c PONTCHAILLOU UNIVERSITY HOSPITAL   (France)

^d HÔPITAL SAINT ELOI   (France)

^e BEAUJON HOSPITAL   (France)

^f HÔPITAL DE HAUTEPIERRE   (France)

^g HÔPITAL DU BOCAGE   (France)

^h MEDICAL UNIVERSITY OF GRAZ   (Austria)

ⁱ HÔPITAL TENON   (France)

Author keywords

Distal pancreatectomy; Multicenter controlled randomized study; Postoperative pancreatic fistula; Prevention; Reinforcement; Stump closure

Indexed keywords

COLLAGEN SPONGE; FIBRINOGEN PLUS THROMBIN; DRUG COMBINATION; FIBRINOGEN; THROMBIN;

ABDOMINAL BLEEDING; ABDOMINAL DRAINAGE; ADULT; AGED; ARTICLE; CANCER SURGERY; CAUSE OF DEATH; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DISEASE SEVERITY; FEMALE; FOLLOW UP; HEART ARRHYTHMIA; HUMAN; INTENSIVE CARE; INTENTION TO TREAT ANALYSIS; INTERMETHOD COMPARISON; INTESTINE OBSTRUCTION; KIDNEY FAILURE; LAPAROSCOPY; LAPAROTOMY; LENGTH OF STAY; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORBIDITY; MORTALITY; MULTICENTER STUDY; OPERATION DURATION; ORGAN PRESERVATION; PANCREAS CANCER; PANCREAS FISTULA; PANCREAS RESECTION; PANCREAS TUMOR; PANCREATIC REMNANT STUMP CLOSURE; PATIENT SAFETY; PERFORATION; PERITONITIS; PLEURA EFFUSION; PNEUMONIA; POSTOPERATIVE COMPLICATION; POSTOPERATIVE PANCREATIC FISTULA; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; PROGNOSTIC ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY DISTRESS; RESPIRATORY FAILURE; SEPSIS; SHOCK; SPLEEN INFARCTION; SPLEEN PRESERVATION; SURGICAL SPONGE; SURGICAL TECHNIQUE; THROMBOPHLEBITIS; TREATMENT OUTCOME; TREATMENT RESPONSE; WARSHAW TECHNIQUE; WOUND DEHISCENCE; ADVERSE EFFECTS; CLINICAL TRIAL; COMPLICATION; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; MIDDLE AGED; PANCREATIC DISEASES; PANCREATIC FISTULA; PATHOLOGY; SUTURING METHOD; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; FIBRINOGEN; HUMANS; MALE; MIDDLE AGED; PANCREATECTOMY; PANCREATIC DISEASES; PANCREATIC FISTULA; SUTURE TECHNIQUES; THROMBIN; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84941937287     PISSN: 00029610     EISSN: 18791883     Source Type: Journal    
DOI: 10.1016/j.amjsurg.2015.04.015     Document Type: Article

References (38)

1. J. Kleeff, M.K. Diener, K. Z'graggen, and et al. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases Ann Surg 245 2007 573 582
2. K.D. Lillemoe, S. Kaushal, J.L. Cameron, and et al. Distal pancreatectomy indications and outcome in 235 patients Ann Surg 229 1999 693 700
3. H.P. Knaebel, M.K. Diener, M.N. Wente, and et al. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy Br J Surg 92 2005 539 546
4. T. Hackert, J. Werner, and M.W. Buchler Postoperative pancreatic fistula Surgeon 9 2011 211 217
5. M. Reeh, M.F. Nentwich, D. Bogoevski, and et al. High surgical morbidity following distal pancreatectomy: still an unsolved problem World J Surg 35 2011 1110 1117
6. K.S. Gurusamy, R. Koti, G. Fusai, and et al. Somatostatin analogues for pancreatic surgery (Review) Cochrane Database Syst Rev 2012 CD008370
7. M.M. Bilimoria, J.N. Cormier, Y. Mun, and et al. Pancreatic leak after left pancreatectomy is reduced following main pancreatic duct ligation Br J Surg 90 2003 190 196
8. C. Bassi, G. Butturini, M. Falconi, and et al. Prospective randomized pilot study of management of the pancreatic stump following distal resection HPB 1 1999 203 207
9. M.K. Diener, C.M. Seiler, I. Rossion, and et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial Lancet 377 2011 1514 1522
10. C.R. Ferrone, A.L. Warshaw, D.W. Rattner, and et al. Pancreatic fistula rates after 462 distal pancreatectomies: staplers do not decrease fistula rates J Gastrointest Surg 12 2008 1691 1698
11. K.C. Conlon, D. Labow, D. Leung, and et al. Prospective randomized clinical trial of the value of intraperitoneal drainage after pancreatic resection Ann Surg 234 2001 487 494
12. C. Bassi, E. Molinari, G. Malleo, and et al. Early versus late drain removal after standard pancreatic resections results of a prospective randomized trial Ann Surg 252 2010 207 214
13. F.M. Johnston, A. Cavataio, S.M. Strasberg, and et al. The effect of mesh reinforcement of a stapled transection line on the rate of pancreatic occlusion failure after distal pancreatectomy: review of a single institution's experience HPB (Oxford) 11 2009 25 31
14. R.I. Thaker, B.D. Matthews, D.C. Linehan, and et al. Absorbable mesh reinforcement of a stapled pancreatic transection line reduces the leak rate with distal pancreatectomy J Gastrointest Surg 11 2007 59 65
15. S. Ohwada, T. Ogawa, T. Tanahashi, and et al. Fibrin glue sandwich prevents fistula following distal pancreatectomy World J Surg 22 1998 494 498
16. V. Velanovich The use of tissue sealant to prevent fistula formation after laparoscopic distal pancreatectomy Surg Endosc 21 2007 1222
17. N.A. Hamilton, M.R. Porembka, F.M. Johnston, and et al. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy: a single-blinded, randomized controlled trial Ann Surg 255 2012 1037 1042
18. T.W. Kraus, A. Mehrabi, P. Schemmer, and et al. Scientific evidence for application of topical hemostats, tissue glues, and sealants in hepatobiliary surgery J Am Coll Surg 200 2005 418 427
19. M. Montorsi, A. Zerbi, C. Bassi, et al. The Italian TachoSil Study Group Efficacy of an absorbable fibrin sealant patch (TachoSil) after distal pancreatectomy: a multicenter, randomized, controlled trial Ann Surg 256 2012 853 860
20. A.L. Warshaw Conservation of the spleen with distal pancreatectomy Arch Surg 123 1988 550 553
21. C. Bassi, C. Dervenis, G. Butturini, et al. for the International Study Group on Pancreatic Fistula Definition Postoperative pancreatic fistula: an international study group (ISGPF) definition Surgery 138 2005 8 13
22. M.L. DeOliveira, J.M. Winter, M. Schafer, and et al. Assessment of complications after pancreatic surgery: a novel grading system applied to 633 patients undergoing pancreaticoduodenectomy Ann Surg 244 2006 931 939
23. H.R. Champion, A. Fingerhut, M.A. Escobar, and et al. The role of data and safety monitoring in acute trauma resuscitation research J Am Coll Surg 204 2007 73 83
24. D. Moher, K.F. Schulz, D.G. Altman for the CONSORT Group The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials Lancet 357 2001 1191 1194
25. S. Hopewell, K. Loudon, M.J. Clarke, and et al. Publication bias in clinical trials due to statistical significance or direction of trial results (Review) Cochrane Database Syst Rev 2009 MR000006
26. K. Dwan, D.G. Altman, J.A. Arnaiz, and et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias PLoS One 3 2008 e3081
27. Rozich N, Matos A, Gegios A, et al. The Effect of Splenectomy on Complication Rates after Distal Pancreatectomy: A Meta-analysis Presented at the Society for Surgery of the Alimentary Tract Orlando May 17-21 2013.
28. J.P. Adam, A. Jacquin, C. Laurent, and et al. Laparoscopic spleen-preserving distal pancreatectomy splenic vessel preservation compared with the Warshaw technique JAMA Surg 148 2013 246 252
29. N. Carrere, S. Abid, C.H. Julio, and et al. Spleen-preserving distal pancreatectomy with excision of splenic artery and vein: a case-matched comparison with conventional distal pancreatectomy with splenectomy World J Surg 31 2007 375 382
30. J.R. Rodriguez, M.G. Madanat, B.C. Healy, and et al. Distal pancreatectomy with splenic preservation revisited Surgery 141 2007 619 625
31. G. Jain, S. Chakravartty, and A.G. Patel Spleen-preserving distal pancreatectomy with and without splenic vessel ligation: a systematic review HPB (Oxford) 15 2013 403 410
32. R. Venkat, B.H. Edil, R.D. Schulick, and et al. Laparoscopic distal pancreatectomy is associated with significantly less overall morbidity compared to the open technique: a systematic review and meta-analysis Ann Surg 255 2012 1048 1059
33. C.S. Cho, D.A. Kooby, C.M. Schmidt, and et al. Laparoscopic versus open left pancreatectomy: can preoperative factors indicate the safer technique? Ann Surg 253 2011 975 980
34. G. Butturini, S. Partelli, S. Crippa, and et al. Perioperative and long-term results after left pancreatectomy: a single-institution, non-randomized, comparative study between open and laparoscopic approach Surg Endosc 25 2011 2871 2878
35. V. Pannageon, P. Pessaux, A. Sauvanet, and et al. Pancreatic fistula after distal pancreatectomy: predictive risk factors and value of conservative treatment Arch Surg 141 2006 1071 1076
36. M. Birth, J. Figueras, S. Bernardini, and et al. Collagen fleece-bound fibrin sealant is not associated with an increased risk of thromboembolic events or major bleeding after its use for haemostasis in surgery: a prospective multicentre surveillance study Patient Saf Surg 3 2009 13 21
37. L. Trinquart, J.P.A. Ioannidis, G. Chatellier, and et al. A test for reporting bias in trial networks: simulation and case studies BMC Med Res Methodol 14 2014 112
38. K. Claxton, J.T. Cohen, and P.J. Neumann When is evidence sufficient? A framework for making use of all available information in medical decision making and for deciding whether more is needed Health Aff 24 2005 93 101