{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T21:25:49Z","timestamp":1790025949699,"version":"4.0.1"},"reference-count":32,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2021,2,10]],"date-time":"2021-02-10T00:00:00Z","timestamp":1612915200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"abstract":"<jats:sec>\n            <jats:title>Introduction:<\/jats:title>\n            <jats:p>Postoperative pancreatic fistula (POPF) is the most dreaded complication after distal pancreatectomy (DP). This multicenter randomized trial evaluated the efficacy, safety, and tolerance of Hemopatch in preventing clinically relevant (grades B\/C according to the ISGPS classification) POPF after DP.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Material and methods:<\/jats:title>\n            <jats:p>After stump closure, patients were randomized to affix Hemopatch to the stump or not. Statistical significance was set at 0.025. Clinical significance was defined as the number of patients needed to treat (NNT) to avoid 1 B\/C POPF.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>Of 631 eligible patients, 360 were randomized and 315 analyzed per protocol (155 in the standard closure group; 160 in the Hemopatch group). The rates of B\/C POPF (the primary endpoint) were 23.2% and 16.3% (<jats:italic toggle=\"yes\">P<\/jats:italic>\u2009=\u20090.120), while the number of patients with 1 or more complications (including patients with B\/C POPF) was 34.8% and 24.4% (<jats:italic toggle=\"yes\">P<\/jats:italic>\u2009=\u20090.049) in the standard and Hemopatch groups, respectively. In patients with hand-sewn stump and main duct closure, the rates were 26.2% versus 10.0% (<jats:italic toggle=\"yes\">P<\/jats:italic>\u2009=\u20090.014) and 23.3% versus 7.7% (<jats:italic toggle=\"yes\">P<\/jats:italic>\u2009=\u20090.015) in the standard and Hemopatch groups, respectively. The NNT in these 2 subgroups was 6 and 6.4, respectively.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion:<\/jats:title>\n            <jats:p>The results of the first randomized trial evaluating Hemopatch-reinforced pancreatic stump after DP to prevent type B\/C POPF do not allow us to conclude that the risk of B\/C POPF was lower. Based on the NNT, however, routine use of Hemopatch after DP may result in fewer complications (including POPF) overall, especially in cases with hand-sewn closure of the pancreatic stump or main pancreatic duct.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1097\/as9.0000000000000033","type":"journal-article","created":{"date-parts":[[2021,2,24]],"date-time":"2021-02-24T01:52:17Z","timestamp":1614131537000},"page":"e033","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":14,"title":["Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial"],"prefix":"10.1097","volume":"2","author":[{"given":"Selman","family":"Uranues","sequence":"first","affiliation":[{"name":"Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abraham","family":"Fingerhut","sequence":"additional","affiliation":[{"name":"Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria"},{"name":"Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Minimally Invasive Surgery Center, Shanghai, P. 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China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orlin","family":"Belyaev","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Allgemein- und Viszeralchirurgie St. Josef-Hospital, Bochum, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Zerbi","sequence":"additional","affiliation":[{"name":"Pancreatic Surgery Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano (MI), Italy Humanitas University, Pieve Emanuele (MI), Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ugo","family":"Boggi","sequence":"additional","affiliation":[{"name":"Division of General and Transplant Surgery, University of Pisa, Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias W.","family":"Hoffmann","sequence":"additional","affiliation":[{"name":"Department of General and Visceral Surgery, Raphaelsklinik M\u00fcnster, M\u00fcnster, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Reim","sequence":"additional","affiliation":[{"name":"Klinik und Poliklinik f\u00fcr Chirurgie, Klinikum Rechts der Isar, Technische Universit\u00e4t M\u00fcnchen, M\u00fcnchen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Esposito","sequence":"additional","affiliation":[{"name":"Department of General and Pancreatic Surgery\u2014Pancreas Institute, University of Verona, Verona Hospital Trust, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Primavesi","sequence":"additional","affiliation":[{"name":"Department of Visceral, Transplant and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria"},{"name":"Department of Surgery, Salzkammergut-Klinikum, V\u00f6cklabruck, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Kornprat","sequence":"additional","affiliation":[{"name":"Clinical Division of General, Visceral and Transplantation Surgery, Medical University of Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Coppola","sequence":"additional","affiliation":[{"name":"Department of Surgery, Campus Bio-Medico University of Rome, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgio P.","family":"Fragulidis","sequence":"additional","affiliation":[{"name":"2nd Department of Surgery \u201cAretaieio\u201d Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Serradilla-Martin","sequence":"additional","affiliation":[{"name":"Department of Surgery, Instituto de Investigaci\u00f3n Sanitaria Arag\u00f3n, Miguel Servet 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