Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trialResearch in context
Summary: Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Metho...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-08-01
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| Series: | The Lancet Regional Health. Europe |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666776223000923 |
| _version_ | 1797785130269409280 |
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| author | Maarten Korrel Leia R. Jones Jony van Hilst Gianpaolo Balzano Bergthor Björnsson Ugo Boggi Svein Olav Bratlie Olivier R. Busch Giovanni Butturini Giovanni Capretti Riccardo Casadei Bjørn Edwin Anouk M.L.H. Emmen Alessandro Esposito Massimo Falconi Bas Groot Koerkamp Tobias Keck Ruben H.J. de Kleine Dyre B. Kleive Arto Kokkola Daan J. Lips Sanne Lof Misha D.P. Luyer Alberto Manzoni Ravi Marudanayagam Matteo de Pastena Nicolò Pecorelli John N. Primrose Claudio Ricci Roberto Salvia Per Sandström Frederique L.I.M. Vissers Ulrich F. Wellner Alessandro Zerbi Marcel G.W. Dijkgraaf Marc G. Besselink Mohammad Abu Hilal Adnan Alseidi Constanza Aquilano Johanna Arola Denise Bianchi Rachel Brown Daniela Campani Joanne ChinAleong Jerome Cros Lyubomira Dimitrova Claudio Doglioni Safi Dokmak Russell Dorer Michael Doukas Jean Michel Fabre Giovanni Ferrari Viacheslay Grinevich Stefano Gobbo Thilo Hackert Marius van den Heuvel Clement Huijsentruijt Mar Iglesias Casper Jansen Igor Khatkov David Kooby Marco Lena Claudio Luchini Krishna Menon Patrick Michenet Quintus Molenaar Anna Nedkova Andrea Pietrabissa Mihaela Raicu Rushda Rajak Branislava Rankovic Aniko Rendek Benjamin Riviere Antonio Sa Cunha Olivier Saint Marc Patricia Sanchez Velazquez Donatella Santini Aldo Scarpa Mylene Sebagh Donald Sears Mihir Shah Zahir Soonawalla Paola Spaggiari Lars Tharun Tore Tholfsen Ales Tomazic Alessandro Vanoli Caroline Verbeke Joanne Verheij Moritz Von Winterfeld Roeland de Wilde Vincent Yip Yoh Zen |
| author_facet | Maarten Korrel Leia R. Jones Jony van Hilst Gianpaolo Balzano Bergthor Björnsson Ugo Boggi Svein Olav Bratlie Olivier R. Busch Giovanni Butturini Giovanni Capretti Riccardo Casadei Bjørn Edwin Anouk M.L.H. Emmen Alessandro Esposito Massimo Falconi Bas Groot Koerkamp Tobias Keck Ruben H.J. de Kleine Dyre B. Kleive Arto Kokkola Daan J. Lips Sanne Lof Misha D.P. Luyer Alberto Manzoni Ravi Marudanayagam Matteo de Pastena Nicolò Pecorelli John N. Primrose Claudio Ricci Roberto Salvia Per Sandström Frederique L.I.M. Vissers Ulrich F. Wellner Alessandro Zerbi Marcel G.W. Dijkgraaf Marc G. Besselink Mohammad Abu Hilal Adnan Alseidi Constanza Aquilano Johanna Arola Denise Bianchi Rachel Brown Daniela Campani Joanne ChinAleong Jerome Cros Lyubomira Dimitrova Claudio Doglioni Safi Dokmak Russell Dorer Michael Doukas Jean Michel Fabre Giovanni Ferrari Viacheslay Grinevich Stefano Gobbo Thilo Hackert Marius van den Heuvel Clement Huijsentruijt Mar Iglesias Casper Jansen Igor Khatkov David Kooby Marco Lena Claudio Luchini Krishna Menon Patrick Michenet Quintus Molenaar Anna Nedkova Andrea Pietrabissa Mihaela Raicu Rushda Rajak Branislava Rankovic Aniko Rendek Benjamin Riviere Antonio Sa Cunha Olivier Saint Marc Patricia Sanchez Velazquez Donatella Santini Aldo Scarpa Mylene Sebagh Donald Sears Mihir Shah Zahir Soonawalla Paola Spaggiari Lars Tharun Tore Tholfsen Ales Tomazic Alessandro Vanoli Caroline Verbeke Joanne Verheij Moritz Von Winterfeld Roeland de Wilde Vincent Yip Yoh Zen |
| author_sort | Maarten Korrel |
| collection | DOAJ |
| description | Summary: Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods: In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of −7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI −6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0–30.0] vs 23.0 [14.0–32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0–30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5–5.5] vs 5 [95% CI 4.7–5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67–1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation: This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding: Medtronic Covidien AG, Johnson & Johnson Medical Limited, Dutch Gastroenterology Society. |
| first_indexed | 2024-03-13T00:49:43Z |
| format | Article |
| id | doaj.art-bcb4c761ba7445f683cf39084a0f3045 |
| institution | Directory Open Access Journal |
| issn | 2666-7762 |
| language | English |
| last_indexed | 2024-03-13T00:49:43Z |
| publishDate | 2023-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Regional Health. Europe |
| spelling | doaj.art-bcb4c761ba7445f683cf39084a0f30452023-07-08T04:19:20ZengElsevierThe Lancet Regional Health. Europe2666-77622023-08-0131100673Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trialResearch in contextMaarten Korrel0Leia R. Jones1Jony van Hilst2Gianpaolo Balzano3Bergthor Björnsson4Ugo Boggi5Svein Olav Bratlie6Olivier R. Busch7Giovanni Butturini8Giovanni Capretti9Riccardo Casadei10Bjørn Edwin11Anouk M.L.H. Emmen12Alessandro Esposito13Massimo Falconi14Bas Groot Koerkamp15Tobias Keck16Ruben H.J. de Kleine17Dyre B. Kleive18Arto Kokkola19Daan J. Lips20Sanne Lof21Misha D.P. Luyer22Alberto Manzoni23Ravi Marudanayagam24Matteo de Pastena25Nicolò Pecorelli26John N. Primrose27Claudio Ricci28Roberto Salvia29Per Sandström30Frederique L.I.M. Vissers31Ulrich F. Wellner32Alessandro Zerbi33Marcel G.W. Dijkgraaf34Marc G. Besselink35Mohammad Abu Hilal36Adnan AlseidiConstanza AquilanoJohanna ArolaDenise BianchiRachel BrownDaniela CampaniJoanne ChinAleongJerome CrosLyubomira DimitrovaClaudio DoglioniSafi DokmakRussell DorerMichael DoukasJean Michel FabreGiovanni FerrariViacheslay GrinevichStefano GobboThilo HackertMarius van den HeuvelClement HuijsentruijtMar IglesiasCasper JansenIgor KhatkovDavid KoobyMarco LenaClaudio LuchiniKrishna MenonPatrick MichenetQuintus MolenaarAnna NedkovaAndrea PietrabissaMihaela RaicuRushda RajakBranislava RankovicAniko RendekBenjamin RiviereAntonio Sa CunhaOlivier Saint MarcPatricia Sanchez VelazquezDonatella SantiniAldo ScarpaMylene SebaghDonald SearsMihir ShahZahir SoonawallaPaola SpaggiariLars TharunTore TholfsenAles TomazicAlessandro VanoliCaroline VerbekeJoanne VerheijMoritz Von WinterfeldRoeland de WildeVincent YipYoh ZenDepartment of General Surgery, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy; Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Cancer Center Amsterdam, the NetherlandsDepartment of General Surgery, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy; Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Cancer Center Amsterdam, the NetherlandsAmsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Cancer Center Amsterdam, the Netherlands; Department of Surgery, OLVG Hospital, Amsterdam, the NetherlandsDepartment of Surgery, San Raffaele Hospital IRCCS, Università Vita-Salute, Milan, ItalyDepartments of Surgery, Biomedical and Clinical Sciences, Linköping University, Linköping, SwedenDepartment of Surgery, Universitá di Pisa, Pisa, ItalyDepartment of Surgery, Sahlgrenska University Hospital, Gothenburg, SwedenAmsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Cancer Center Amsterdam, the NetherlandsDepartment of Surgery, Pederzoli Hospital, Peschiera, ItalyPancreatic Surgery, Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; IRCCS Humanitas Research Hospital, Rozzano, ItalyDivision of Pancreatic Surgery IRCCS, S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, ItalyThe Intervention Center, Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, NorwayDepartment of General Surgery, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy; Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Cancer Center Amsterdam, the NetherlandsDepartment of General and Pancreatic Surgery - Pancreas Institute, University Hospital of Verona, Verona, ItalyDepartment of Surgery, San Raffaele Hospital IRCCS, Università Vita-Salute, Milan, ItalyDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsDepartment of Surgery, UKSH Campus Lübeck, Lübeck, GermanyDepartment of Surgery, University Medical Centre Groningen, Groningen, the NetherlandsDepartment of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Rikshospitalet, Oslo, NorwayDepartment of Surgery, Helsinki University Hospital, Helsinki, FinlandDepartment of Surgery, Medisch Spectrum Twente, Enschede, the NetherlandsAmsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Department of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UKDepartment of Surgery, Catharina Ziekenhuis, Eindhoven, the NetherlandsDepartment of General Surgery, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, ItalyDepartment of HPB Surgery, University Hospital Birmingham, Birmingham, UKDepartment of General and Pancreatic Surgery - Pancreas Institute, University Hospital of Verona, Verona, ItalyDepartment of Surgery, San Raffaele Hospital IRCCS, Università Vita-Salute, Milan, ItalyDepartment of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UKDivision of Pancreatic Surgery IRCCS, S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, ItalyDepartment of General and Pancreatic Surgery - Pancreas Institute, University Hospital of Verona, Verona, ItalyDepartments of Surgery, Biomedical and Clinical Sciences, Linköping University, Linköping, SwedenAmsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Cancer Center Amsterdam, the NetherlandsDepartment of Surgery, UKSH Campus Lübeck, Lübeck, GermanyPancreatic Surgery, Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; IRCCS Humanitas Research Hospital, Rozzano, ItalyAmsterdam UMC, University of Amsterdam, Department of Epidemiology and Data Science, Amsterdam, the Netherlands; Amsterdam Public Health, Methodology, Amsterdam, the NetherlandsAmsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands; Cancer Center Amsterdam, the Netherlands; Corresponding author. Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Department of Surgery, the Netherlands.Department of General Surgery, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy; Department of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Corresponding author. Department of Surgery, Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy.Summary: Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods: In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of −7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI −6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0–30.0] vs 23.0 [14.0–32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0–30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5–5.5] vs 5 [95% CI 4.7–5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67–1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation: This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding: Medtronic Covidien AG, Johnson & Johnson Medical Limited, Dutch Gastroenterology Society.http://www.sciencedirect.com/science/article/pii/S2666776223000923Distal pancreatectomyPancreatic ductal adenocarcinomaMinimally invasive surgery |
| spellingShingle | Maarten Korrel Leia R. Jones Jony van Hilst Gianpaolo Balzano Bergthor Björnsson Ugo Boggi Svein Olav Bratlie Olivier R. Busch Giovanni Butturini Giovanni Capretti Riccardo Casadei Bjørn Edwin Anouk M.L.H. Emmen Alessandro Esposito Massimo Falconi Bas Groot Koerkamp Tobias Keck Ruben H.J. de Kleine Dyre B. Kleive Arto Kokkola Daan J. Lips Sanne Lof Misha D.P. Luyer Alberto Manzoni Ravi Marudanayagam Matteo de Pastena Nicolò Pecorelli John N. Primrose Claudio Ricci Roberto Salvia Per Sandström Frederique L.I.M. Vissers Ulrich F. Wellner Alessandro Zerbi Marcel G.W. Dijkgraaf Marc G. Besselink Mohammad Abu Hilal Adnan Alseidi Constanza Aquilano Johanna Arola Denise Bianchi Rachel Brown Daniela Campani Joanne ChinAleong Jerome Cros Lyubomira Dimitrova Claudio Doglioni Safi Dokmak Russell Dorer Michael Doukas Jean Michel Fabre Giovanni Ferrari Viacheslay Grinevich Stefano Gobbo Thilo Hackert Marius van den Heuvel Clement Huijsentruijt Mar Iglesias Casper Jansen Igor Khatkov David Kooby Marco Lena Claudio Luchini Krishna Menon Patrick Michenet Quintus Molenaar Anna Nedkova Andrea Pietrabissa Mihaela Raicu Rushda Rajak Branislava Rankovic Aniko Rendek Benjamin Riviere Antonio Sa Cunha Olivier Saint Marc Patricia Sanchez Velazquez Donatella Santini Aldo Scarpa Mylene Sebagh Donald Sears Mihir Shah Zahir Soonawalla Paola Spaggiari Lars Tharun Tore Tholfsen Ales Tomazic Alessandro Vanoli Caroline Verbeke Joanne Verheij Moritz Von Winterfeld Roeland de Wilde Vincent Yip Yoh Zen Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trialResearch in context The Lancet Regional Health. Europe Distal pancreatectomy Pancreatic ductal adenocarcinoma Minimally invasive surgery |
| title | Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trialResearch in context |
| title_full | Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trialResearch in context |
| title_fullStr | Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trialResearch in context |
| title_full_unstemmed | Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trialResearch in context |
| title_short | Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trialResearch in context |
| title_sort | minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer diploma an international randomised non inferiority trialresearch in context |
| topic | Distal pancreatectomy Pancreatic ductal adenocarcinoma Minimally invasive surgery |
| url | http://www.sciencedirect.com/science/article/pii/S2666776223000923 |
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