Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial
Introduction:. 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)...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Health
2021-03-01
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| Series: | Annals of Surgery Open |
| Online Access: | http://journals.lww.com/10.1097/AS9.0000000000000033 |
| _version_ | 1827856004139712512 |
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| author | Selman Uranues Abraham Fingerhut Orlin Belyaev Alessandro Zerbi Ugo Boggi Matthias W. Hoffmann Daniel Reim Alessandro Esposito Florian Primavesi Peter Kornprat Roberto Coppola Georgio P. Fragulidis Mario Serradilla-Martin Orhan Alimoglu Andrea Peri Bogdan Diaconescu |
| author_facet | Selman Uranues Abraham Fingerhut Orlin Belyaev Alessandro Zerbi Ugo Boggi Matthias W. Hoffmann Daniel Reim Alessandro Esposito Florian Primavesi Peter Kornprat Roberto Coppola Georgio P. Fragulidis Mario Serradilla-Martin Orhan Alimoglu Andrea Peri Bogdan Diaconescu |
| author_sort | Selman Uranues |
| collection | DOAJ |
| description | Introduction:. 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.
Material and methods:. 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.
Results:. 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% (P = 0.120), while the number of patients with 1 or more complications (including patients with B/C POPF) was 34.8% and 24.4% (P = 0.049) 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% (P = 0.014) and 23.3% versus 7.7% (P = 0.015) in the standard and Hemopatch groups, respectively. The NNT in these 2 subgroups was 6 and 6.4, respectively.
Conclusion:. 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. |
| first_indexed | 2024-03-12T12:19:28Z |
| format | Article |
| id | doaj.art-3862dc0005334cf78a79ddff0f832ed6 |
| institution | Directory Open Access Journal |
| issn | 2691-3593 |
| language | English |
| last_indexed | 2024-03-12T12:19:28Z |
| publishDate | 2021-03-01 |
| publisher | Wolters Kluwer Health |
| record_format | Article |
| series | Annals of Surgery Open |
| spelling | doaj.art-3862dc0005334cf78a79ddff0f832ed62023-08-30T06:08:25ZengWolters Kluwer HealthAnnals of Surgery Open2691-35932021-03-0121e03310.1097/AS9.0000000000000033202103000-00011Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized TrialSelman Uranues0Abraham Fingerhut1Orlin Belyaev2Alessandro Zerbi3Ugo Boggi4Matthias W. Hoffmann5Daniel Reim6Alessandro Esposito7Florian Primavesi8Peter Kornprat9Roberto Coppola10Georgio P. Fragulidis11Mario Serradilla-Martin12Orhan Alimoglu13Andrea Peri14Bogdan Diaconescu15From the * Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, AustriaFrom the * Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria‡ Klinik für Allgemein- und Viszeralchirurgie St. Josef-Hospital, Bochum, Germany§ Pancreatic Surgery Unit, Humanitas Clinical and Research Center-IRCCS, Rozzano (MI), Italy Humanitas University, Pieve Emanuele (MI), Italy∥ Division of General and Transplant Surgery, University of Pisa, Pisa, Italy¶ Department of General and Visceral Surgery, Raphaelsklinik Münster, Münster, Germany# Klinik und Poliklinik für Chirurgie, Klinikum Rechts der Isar, Technische Universität München, München, Germany** Department of General and Pancreatic Surgery—Pancreas Institute, University of Verona, Verona Hospital Trust, Verona, Italy†† Department of Visceral, Transplant and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria§§ Clinical Division of General, Visceral and Transplantation Surgery, Medical University of Graz, Austria∥∥ Department of Surgery, Campus Bio-Medico University of Rome, Rome, Italy¶¶ 2nd Department of Surgery “Aretaieio” Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece## Department of Surgery, Instituto de Investigación Sanitaria Aragón, Miguel Servet University Hospital, Zaragoza, Spain*** Department of General Surgery, Faculty of Medicine, Istanbul Medeniyet University Goztepe Training & Research Hospital, Istanbul, Turkey††† General Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy‡‡‡ Anatomy Department, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.Introduction:. 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. Material and methods:. 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. Results:. 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% (P = 0.120), while the number of patients with 1 or more complications (including patients with B/C POPF) was 34.8% and 24.4% (P = 0.049) 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% (P = 0.014) and 23.3% versus 7.7% (P = 0.015) in the standard and Hemopatch groups, respectively. The NNT in these 2 subgroups was 6 and 6.4, respectively. Conclusion:. 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.http://journals.lww.com/10.1097/AS9.0000000000000033 |
| spellingShingle | Selman Uranues Abraham Fingerhut Orlin Belyaev Alessandro Zerbi Ugo Boggi Matthias W. Hoffmann Daniel Reim Alessandro Esposito Florian Primavesi Peter Kornprat Roberto Coppola Georgio P. Fragulidis Mario Serradilla-Martin Orhan Alimoglu Andrea Peri Bogdan Diaconescu Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial Annals of Surgery Open |
| title | Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial |
| title_full | Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial |
| title_fullStr | Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial |
| title_full_unstemmed | Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial |
| title_short | Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial |
| title_sort | clinical impact of stump closure reinforced with hemopatch on the prevention of clinically relevant pancreatic fistula after distal pancreatectomy a multicenter randomized trial |
| url | http://journals.lww.com/10.1097/AS9.0000000000000033 |
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