{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T21:26:13Z","timestamp":1790025973300,"version":"4.0.1"},"reference-count":41,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2021,2,6]],"date-time":"2021-02-06T00:00:00Z","timestamp":1612569600000},"content-version":"vor","delay-in-days":1026,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008373","name":"Takeda Pharmaceutical Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008373","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,5,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The potential for a fibrin sealant patch to reduce the risk of postoperative pancreatic fistula (POPF) remains uncertain. The aim of this study was to evaluate whether a fibrin sealant patch is able to reduce POPF in patients undergoing pancreatoduodenectomy with pancreatojejunostomy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this multicentre trial, patients undergoing pancreatoduodenectomy were randomized to receive either a fibrin patch (patch group) or no patch (control group), and stratified by gland texture, pancreatic duct size and neoadjuvant treatment. The primary endpoint was POPF. Secondary endpoints included complications, drain-related factors and duration of hospital stay. Risk factors for POPF were identified by logistic regression analysis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 142 patients were enrolled. Forty-five of 71 patients (63 per cent) in the patch group and 40 of 71 (56 per cent) in the control group developed biochemical leakage or POPF (P = 0\u00b7392). Fistulas were classified as grade B or C in 16 (23 per cent) and ten (14 per cent) patients respectively (P = 0\u00b7277). There were no differences in postoperative complications (54 patients in patch group and 50 in control group; P = 0\u00b7839), drain amylase concentration (P = 0\u00b7494), time until drain removal (mean(s.d.) 11\u00b76(1\u00b70) versus 13\u00b73(1\u00b73) days; P = 0\u00b7613), fistula closure (17\u00b76(2\u00b72) versus 16\u00b75(2\u00b71) days; P = 0\u00b7740) and duration of hospital stay (22\u00b71(2\u00b72) versus 18\u00b72(0\u00b79) days; P = 0\u00b7810) between the two groups. Multivariable logistic regression analysis confirmed that obesity (odds ratio (OR) 5\u00b728, 95 per cent c.i. 1\u00b720 to 23\u00b718; P = 0\u00b7027), soft gland texture (OR 9\u00b786, 3\u00b741 to 28\u00b754; P &amp;lt; 0\u00b7001) and a small duct (OR 5\u00b750, 1\u00b784 to 16\u00b744; P = 0\u00b7002) were significant risk factors for POPF. A patch did not reduce the incidence of POPF in patients at higher risk.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The use of a fibrin sealant patch did not reduce the occurrence of POPF and complications after pancreatoduodenectomy with pancreatojejunostomy. Registration number: 2013-000639-29 (EudraCT register).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1002\/bjs.10840","type":"journal-article","created":{"date-parts":[[2018,4,17]],"date-time":"2018-04-17T19:14:04Z","timestamp":1523992444000},"page":"811-819","source":"Crossref","is-referenced-by-count":42,"title":["Randomized clinical trial of the effect of a fibrin sealant patch on pancreatic fistula formation after pancreatoduodenectomy"],"prefix":"10.1093","volume":"105","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0941-2127","authenticated-orcid":false,"given":"M","family":"Schindl","sequence":"first","affiliation":[{"name":"Department of Surgery, Medical University of Vienna \u2013 General Hospital, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R","family":"F\u00fcgger","sequence":"additional","affiliation":[{"name":"Department of Surgery, Hospital Elisabethinen, Linz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"G\u00f6tzinger","sequence":"additional","affiliation":[{"name":"Department of Surgery, University Hospital St P\u00f6lten, St P\u00f6lten, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F","family":"L\u00e4ngle","sequence":"additional","affiliation":[{"name":"Department of Surgery, State Hospital Wiener Neustadt, Wiener Neustadt, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Zitt","sequence":"additional","affiliation":[{"name":"Department of Surgery, Medical University of Innsbruck, Innsbruck, Austria"},{"name":"Department of Surgery, District Hospital Dornbirn, Dornbirn, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"St\u00e4ttner","sequence":"additional","affiliation":[{"name":"Department of Surgery, Medical University of Innsbruck, Innsbruck, Austria"},{"name":"Department of Surgery, Medical University of Salzburg, Salzburg, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"Kornprat","sequence":"additional","affiliation":[{"name":"Department of Surgery, Medical University of Graz, Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K","family":"Sahora","sequence":"additional","affiliation":[{"name":"Department of Surgery, Medical University of Vienna \u2013 General Hospital, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Hlauschek","sequence":"additional","affiliation":[{"name":"Department of Statistics, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Gnant","sequence":"additional","affiliation":[{"name":"Department of Surgery, Medical University of Vienna \u2013 General Hospital, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2018,4,17]]},"reference":[{"key":"2021020616580480400_bjs10840-bib-0001","doi-asserted-by":"crossref","first-page":"584","DOI":"10.1016\/j.surg.2016.11.014","article-title":"International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after","volume":"161","author":"Bassi","year":"2017","journal-title":"Surgery"},{"key":"2021020616580480400_bjs10840-bib-0002","article-title":"Clinical implications of the 2016 International Study Group on Pancreatic Surgery definition and grading of postoperative pancreatic fistula on 775 consecutive pancreatic resections","author":"Pulvirenti","year":"2017","journal-title":"Ann Surg"},{"key":"2021020616580480400_bjs10840-bib-0003","article-title":"Characterization and optimal management of high-risk pancreatic anastomoses during pancreatoduodenectomy","author":"Ecker","year":"2017","journal-title":"Ann Surg"},{"key":"2021020616580480400_bjs10840-bib-0004","doi-asserted-by":"crossref","first-page":"954","DOI":"10.1111\/hpb.12314","article-title":"Prophylactic octreotide for pancreatoduodenectomy: more harm than good?","volume":"16","author":"McMillan","year":"2014","journal-title":"HPB (Oxford)"},{"key":"2021020616580480400_bjs10840-bib-0005","doi-asserted-by":"crossref","first-page":"1221","DOI":"10.1016\/j.surg.2016.11.021","article-title":"Pancreatic anastomosis after pancreatoduodenectomy: a position statement by the International Study Group of Pancreatic Surgery (ISGPS)","volume":"161","author":"Shrikhande","year":"2017","journal-title":"Surgery"},{"key":"2021020616580480400_bjs10840-bib-0006","doi-asserted-by":"crossref","first-page":"741","DOI":"10.1002\/bjs.6634","article-title":"Blumgart anastomosis for pancreaticojejunostomy minimizes severe complications after pancreatic head resection","volume":"96","author":"Kleespies","year":"2009","journal-title":"Br J Surg"},{"key":"2021020616580480400_bjs10840-bib-0007","doi-asserted-by":"crossref","first-page":"1597","DOI":"10.1002\/bjs.9252","article-title":"Randomized clinical trial of pancreaticogastrostomy versus pancreaticojejunostomy on the rate and severity of pancreatic fistula after pancreaticoduodenectomy","volume":"100","author":"Figueras","year":"2013","journal-title":"Br J Surg"},{"key":"2021020616580480400_bjs10840-bib-0008","doi-asserted-by":"crossref","first-page":"668","DOI":"10.1002\/bjs.10160","article-title":"Randomized multicentre trial comparing external and internal pancreatic stenting during pancreaticoduodenectomy","volume":"103","author":"Jang","year":"2016","journal-title":"Br J Surg"},{"key":"2021020616580480400_bjs10840-bib-0009","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.jamcollsurg.2012.09.002","article-title":"A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy","volume":"216","author":"Callery","year":"2013","journal-title":"J Am Coll Surg"},{"key":"2021020616580480400_bjs10840-bib-0010","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1002\/bjs.10727","article-title":"Randomized clinical trial of duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy","volume":"105","author":"Senda","year":"2017","journal-title":"Br J Surg"},{"key":"2021020616580480400_bjs10840-bib-0011","doi-asserted-by":"crossref","first-page":"1196","DOI":"10.1002\/bjs.9553","article-title":"Meta-analysis of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy","volume":"101","author":"Xiong","year":"2014","journal-title":"Br J Surg"},{"key":"2021020616580480400_bjs10840-bib-0012","doi-asserted-by":"crossref","first-page":"524","DOI":"10.1002\/bjs.8654","article-title":"Randomized clinical trial of external stent drainage of the pancreatic duct to reduce postoperative pancreatic fistula after pancreaticojejunostomy","volume":"99","author":"Motoi","year":"2012","journal-title":"Br J Surg"},{"issue":"2","key":"2021020616580480400_bjs10840-bib-0013","first-page":"CD009621","article-title":"Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery","author":"Cheng","year":"2016","journal-title":"Cochrane Database Syst Rev"},{"key":"2021020616580480400_bjs10840-bib-0014","doi-asserted-by":"crossref","first-page":"198","DOI":"10.1016\/j.ejcts.2006.11.033","article-title":"Efficiency of fleece-bound sealing (TachoSil) of air leaks in lung surgery: a prospective randomised trial","volume":"31","author":"Anegg","year":"2007","journal-title":"Eur J Cardiothorac Surg"},{"issue":"1","key":"2021020616580480400_bjs10840-bib-0015","first-page":"CD003051","article-title":"Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer","author":"Belda-Sanch\u00eds","year":"2010","journal-title":"Cochrane Database Syst Rev"},{"key":"2021020616580480400_bjs10840-bib-0016","doi-asserted-by":"crossref","first-page":"2285","DOI":"10.1016\/j.juro.2009.07.033","article-title":"The use of a surgical patch in the prevention of lymphoceles after extraperitoneal pelvic lymphadenectomy for prostate cancer: a randomized prospective pilot study","volume":"182","author":"Simonato","year":"2009","journal-title":"J Urol"},{"key":"2021020616580480400_bjs10840-bib-0017","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1016\/j.ejogrb.2015.12.005","article-title":"The contribution of a collagen\u2013fibrin patch (Tachosil) to prevent the postoperative lymphatic complications after groin lymphadenectomy: a double institution observational study","volume":"197","author":"Buda","year":"2016","journal-title":"Eur J Obstet Gynecol Reprod Biol"},{"key":"2021020616580480400_bjs10840-bib-0018","doi-asserted-by":"crossref","first-page":"1283","DOI":"10.1097\/IGC.0000000000001051","article-title":"The efficacy of fibrin sealant patches in reducing the incidence of lymphatic morbidity after radical lymphadenectomy: a meta-analysis","volume":"27","author":"Gasparri","year":"2017","journal-title":"Int J Gynecol Cancer"},{"key":"2021020616580480400_bjs10840-bib-0019","doi-asserted-by":"crossref","first-page":"e0151533","DOI":"10.1371\/journal.pone.0151533","article-title":"Fibrin sealants in dura sealing: a systematic literature review","volume":"11","author":"Esposito","year":"2016","journal-title":"PLoS One"},{"key":"2021020616580480400_bjs10840-bib-0020","doi-asserted-by":"crossref","first-page":"847","DOI":"10.1093\/neuros\/nyx024","article-title":"Safety and efficacy of TachoSil (absorbable fibrin sealant patch) compared with current practice for the prevention of cerebrospinal fluid leaks in patients undergoing skull base surgery: a randomized controlled trial","volume":"80","author":"George","year":"2017","journal-title":"Neurosurgery"},{"key":"2021020616580480400_bjs10840-bib-0021","doi-asserted-by":"crossref","first-page":"151","DOI":"10.1007\/s00423-016-1382-7","article-title":"Effectiveness of Tachosil\u00ae in the prevention of postoperative pancreatic fistula after distal pancreatectomy: a systematic review and meta-analysis","volume":"401","author":"H\u00fcttner","year":"2016","journal-title":"Langenbecks Arch Surg"},{"key":"2021020616580480400_bjs10840-bib-0022","doi-asserted-by":"crossref","first-page":"1033","DOI":"10.1111\/hpb.12472","article-title":"Systematic review on the use of matrix-bound sealants in pancreatic resection","volume":"17","author":"Smits","year":"2015","journal-title":"HPB (Oxford)"},{"key":"2021020616580480400_bjs10840-bib-0023","doi-asserted-by":"crossref","first-page":"1396","DOI":"10.1007\/s11605-009-0894-7","article-title":"Pancreaticojejunostomy with application of fibrinogen\/thrombin-coated collagen patch (TachoSil) in Roux-en-Y reconstruction after pancreaticoduodenectomy","volume":"13","author":"Chirletti","year":"2009","journal-title":"J Gastrointest Surg"},{"key":"2021020616580480400_bjs10840-bib-0024","first-page":"187","article-title":"Pancreaticojejunostomy using a fibrin adhesive sealant (TachoComb) for the prevention of pancreatic fistula after pancreaticoduodenectomy","volume":"58","author":"Mita","year":"2011","journal-title":"Hepatogastroenterology"},{"key":"2021020616580480400_bjs10840-bib-0025","doi-asserted-by":"crossref","first-page":"c332","DOI":"10.1136\/bmj.c332","article-title":"CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials","volume":"340","author":"Schulz","year":"2010","journal-title":"BMJ"},{"key":"2021020616580480400_bjs10840-bib-0026","doi-asserted-by":"crossref","first-page":"103","DOI":"10.2307\/2529712","article-title":"Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial","volume":"31","author":"Pocock","year":"1975","journal-title":"Biometrics"},{"key":"2021020616580480400_bjs10840-bib-0027","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1016\/j.surg.2005.05.001","article-title":"International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition","volume":"138","author":"Bassi","year":"2005","journal-title":"Surgery"},{"key":"2021020616580480400_bjs10840-bib-0028","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1097\/SLA.0b013e3181b13ca2","article-title":"The Clavien\u2013Dindo classification of surgical complications: five-year experience","volume":"250","author":"Clavien","year":"2009","journal-title":"Ann Surg"},{"key":"2021020616580480400_bjs10840-bib-0029","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1007\/s10353-016-0436-y","article-title":"Surgical use of fibrin glue-coated collagen patch for non-hemostatic indications","volume":"48","author":"Sampanis","year":"2016","journal-title":"Eur Surg"},{"key":"2021020616580480400_bjs10840-bib-0030","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1002\/jhbp.389","article-title":"An update on topical haemostatic agents in liver surgery: systematic review and meta analysis","volume":"23","author":"Brustia","year":"2016","journal-title":"J Hepatobiliary Pancreat Sci"},{"key":"2021020616580480400_bjs10840-bib-0031","doi-asserted-by":"crossref","first-page":"352","DOI":"10.1080\/08941939.2016.1181229","article-title":"Efficacy of human fibrinogen\u2013thrombin patch (TachoSil) clinical application in upper gastrointestinal cancer surgery","volume":"29","author":"Marano","year":"2016","journal-title":"J Invest Surg"},{"key":"2021020616580480400_bjs10840-bib-0032","doi-asserted-by":"crossref","first-page":"627","DOI":"10.4240\/wjgs.v8.i9.627","article-title":"Fibrinogen\u2013thrombin collagen patch reinforcement of high-risk colonic anastomoses in rats","volume":"8","author":"Su\u00e1rez-Grau","year":"2016","journal-title":"World J Gastrointest Surg"},{"key":"2021020616580480400_bjs10840-bib-0033","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1002\/jhbp.310","article-title":"Use of TachoSil\u00ae patches to prevent pancreatic leaks after distal pancreatectomy: a prospective, multicenter, randomized controlled study","volume":"23","author":"Park","year":"2016","journal-title":"J Hepatobiliary Pancreat Sci"},{"key":"2021020616580480400_bjs10840-bib-0034","doi-asserted-by":"crossref","first-page":"853","DOI":"10.1097\/SLA.0b013e318272dec0","article-title":"Efficacy of an absorbable fibrin sealant patch (TachoSil) after distal pancreatectomy: a multicenter, randomized, controlled trial","volume":"256","author":"Montorsi","year":"2012","journal-title":"Ann Surg"},{"key":"2021020616580480400_bjs10840-bib-0035","first-page":"636824","article-title":"Pancreaticojejuno anastomosis after pancreaticoduodenectomy: brief pathophysiological considerations for a rational surgical choice","volume":"2012","author":"Caronna","year":"2012","journal-title":"Int J Surg Oncol"},{"key":"2021020616580480400_bjs10840-bib-0036","doi-asserted-by":"crossref","first-page":"1498","DOI":"10.1002\/bjs.9243","article-title":"In vitro effects of proteases in human pancreatic juice on stability of liquid and carrier-bound fibrin sealants","volume":"100","author":"Adelmeijer","year":"2013","journal-title":"Br J Surg"},{"key":"2021020616580480400_bjs10840-bib-0037","doi-asserted-by":"crossref","first-page":"1074","DOI":"10.1001\/archsurg.2009.193","article-title":"Measures to prevent pancreatic fistula after pancreatoduodenectomy: a comprehensive review","volume":"144","author":"Lai","year":"2009","journal-title":"Arch Surg"},{"key":"2021020616580480400_bjs10840-bib-0038","doi-asserted-by":"crossref","first-page":"591","DOI":"10.1016\/S1072-7515(98)00243-9","article-title":"Results of a technique of pancreaticojejunostomy that optimizes blood supply to the pancreas","volume":"187","author":"Strasberg","year":"1998","journal-title":"J Am Coll Surg"},{"key":"2021020616580480400_bjs10840-bib-0039","doi-asserted-by":"crossref","first-page":"642","DOI":"10.1016\/j.hpb.2016.05.006","article-title":"Defining post-operative pancreatitis as a new pancreatic specific complication following pancreatic resection","volume":"18","author":"Connor","year":"2016","journal-title":"HPB (Oxford)"},{"key":"2021020616580480400_bjs10840-bib-0040","doi-asserted-by":"crossref","first-page":"746","DOI":"10.1016\/S1072-7515(02)01202-4","article-title":"Prospective trial of a blood supply-based technique of pancreaticojejunostomy: effect on anastomotic failure in the Whipple procedure","volume":"194","author":"Strasberg","year":"2002","journal-title":"J Am Coll Surg"},{"key":"2021020616580480400_bjs10840-bib-0041","doi-asserted-by":"crossref","first-page":"872","DOI":"10.1016\/j.surg.2015.09.014","article-title":"Postoperative pancreatic fistula: we need to redefine grades B and C","volume":"159","author":"Hackert","year":"2016","journal-title":"Surgery"}],"container-title":["British Journal of Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fbjs.10840","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/academic.oup.com\/bjs\/article-pdf\/105\/7\/811\/36205871\/bjs10840.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/bjs\/article-pdf\/105\/7\/811\/36205871\/bjs10840.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,5,20]],"date-time":"2021-05-20T14:19:35Z","timestamp":1621520375000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/bjs\/article\/105\/7\/811-819\/6123247"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,4,17]]},"references-count":41,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2018,4,17]]},"published-print":{"date-parts":[[2018,5,14]]}},"URL":"https:\/\/doi.org\/10.1002\/bjs.10840","relation":{},"ISSN":["0007-1323","1365-2168"],"issn-type":[{"value":"0007-1323","type":"print"},{"value":"1365-2168","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2018,6]]},"published":{"date-parts":[[2018,4,17]]}}}