Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trialResearch in context
Summary: Background: Major liver resection is often required for complete clearance of colorectal liver metastases (CRLM). Patients with insufficient future liver remnant (FLR) volume/function are at high risk of post-hepatectomy liver failure (PHLF) and require FLR hypertrophy-inducing procedures...
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2025-06-01
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| author | Remon Korenblik Sinéad James Jens Smits Rafael Díaz-Nieto Rob Davis Benjamin K.Y. Chan Joris I. Erdmann IJsbrand A.J. Zijlstra Pieter J.W. Arntz Otto Kollmar Martin H. Hoffmann David G. Vass Richard Lindsay Matteo Serenari Alberto Cappelli Paul D. Gobardhan Farshad Imani Yiliam Fundora Suarez Fernando Gómez Muños Dirk J. Grünhagen Adriaan Moelker Kay J. Pieterman Jörg Kleeff Walter A. Wohlgemuth Eric Herrero Arantxa Gelabert Stefan Breitenstein Nico Seeger Olivier Detry Laurent Gerard Per A. Sandström Bergthor Björnsson Luca A. Aldrighetti Francesco De Cobelli Wouter K.G. Leclercq Laurens J. van Baardewijk Daniel Croagh Diederick W. De Boo T. Peter Kingham Fourat Ridouani Peter Metrakos David Valenti Jennifer Kalil Åsmund A. Fretland Ulrik Carling Guillaume Martel Stephen Ryan Venkatesha Udupa Andrew Macdonald Jordan C. Tasse Gregor A. Stavrou Elmar Spuentrup Francisco G. Borobia Eva Criado Ernesto Sparrelid Martin Delle Jordi Navinés-López Jaume Sampere Moragues Esteban Cugat Andorrà Andreas Schnitzbauer Thomas J. Vogl Jan Heil John N. Primrose Sachin Modi Suomi M.G. Fouraschen Reinoud P.H. Bokkers Marieke T. de Boer Inne H.M. Borel Rinkes Maarten L.J. Smits Thomas Gruenberger Ivan Baclija Kevin G. Billingsley David C. Madoff Alejandro Serrablo Luis Sarriá Xiaoying Wang Qu Xudong Bjorn Winkens Steven W.L. Olde Damink Marc H.A. Bemelmans Maxime J.L. Dewulf Christoph A. Binkert Erik Schadde Christiaan van der Leij Ronald M. van Dam M. Abu Hilal C. Aloman K. Brousseau R.C.G. Bruijnen M. Cescon B. Chand J. Codina Font M. Crawford S.W. de Boer J.F. De Wispelaere A. Dili M. Dixon J. Engstrand A. Erbahceci Salik S.W. Fenwick O. Fisher S. Gilg F. Giuliante L.F. Grochola J. Hagendoorn M.H. Heijmans G.F. Hess R. Iezzi R. Jones G. Kazemier S. Kern R.R.M.M. Knapen C. Lambrecht S. Lopez-Ben V. Lucidi D. Maclean H. Malik G. Maleux M.R. Meijerink J. Melenhorst K. Menon D. Murphy B. Olij J.E. Oor S. Pappas P. Peddu F. Ratti M. Ravaioli C. Rogan U. Ronellenfitsch S. Ross C. Sallemi L.A. Sahan R.J. Swijnenburg I. Tancredi O.M. Van Delden A.L. van der Velden M. Vandermeulen R. Widyaningsih R. Young |
| author_facet | Remon Korenblik Sinéad James Jens Smits Rafael Díaz-Nieto Rob Davis Benjamin K.Y. Chan Joris I. Erdmann IJsbrand A.J. Zijlstra Pieter J.W. Arntz Otto Kollmar Martin H. Hoffmann David G. Vass Richard Lindsay Matteo Serenari Alberto Cappelli Paul D. Gobardhan Farshad Imani Yiliam Fundora Suarez Fernando Gómez Muños Dirk J. Grünhagen Adriaan Moelker Kay J. Pieterman Jörg Kleeff Walter A. Wohlgemuth Eric Herrero Arantxa Gelabert Stefan Breitenstein Nico Seeger Olivier Detry Laurent Gerard Per A. Sandström Bergthor Björnsson Luca A. Aldrighetti Francesco De Cobelli Wouter K.G. Leclercq Laurens J. van Baardewijk Daniel Croagh Diederick W. De Boo T. Peter Kingham Fourat Ridouani Peter Metrakos David Valenti Jennifer Kalil Åsmund A. Fretland Ulrik Carling Guillaume Martel Stephen Ryan Venkatesha Udupa Andrew Macdonald Jordan C. Tasse Gregor A. Stavrou Elmar Spuentrup Francisco G. Borobia Eva Criado Ernesto Sparrelid Martin Delle Jordi Navinés-López Jaume Sampere Moragues Esteban Cugat Andorrà Andreas Schnitzbauer Thomas J. Vogl Jan Heil John N. Primrose Sachin Modi Suomi M.G. Fouraschen Reinoud P.H. Bokkers Marieke T. de Boer Inne H.M. Borel Rinkes Maarten L.J. Smits Thomas Gruenberger Ivan Baclija Kevin G. Billingsley David C. Madoff Alejandro Serrablo Luis Sarriá Xiaoying Wang Qu Xudong Bjorn Winkens Steven W.L. Olde Damink Marc H.A. Bemelmans Maxime J.L. Dewulf Christoph A. Binkert Erik Schadde Christiaan van der Leij Ronald M. van Dam M. Abu Hilal C. Aloman K. Brousseau R.C.G. Bruijnen M. Cescon B. Chand J. Codina Font M. Crawford S.W. de Boer J.F. De Wispelaere A. Dili M. Dixon J. Engstrand A. Erbahceci Salik S.W. Fenwick O. Fisher S. Gilg F. Giuliante L.F. Grochola J. Hagendoorn M.H. Heijmans G.F. Hess R. Iezzi R. Jones G. Kazemier S. Kern R.R.M.M. Knapen C. Lambrecht S. Lopez-Ben V. Lucidi D. Maclean H. Malik G. Maleux M.R. Meijerink J. Melenhorst K. Menon D. Murphy B. Olij J.E. Oor S. Pappas P. Peddu F. Ratti M. Ravaioli C. Rogan U. Ronellenfitsch S. Ross C. Sallemi L.A. Sahan R.J. Swijnenburg I. Tancredi O.M. Van Delden A.L. van der Velden M. Vandermeulen R. Widyaningsih R. Young |
| author_sort | Remon Korenblik |
| collection | DOAJ |
| description | Summary: Background: Major liver resection is often required for complete clearance of colorectal liver metastases (CRLM). Patients with insufficient future liver remnant (FLR) volume/function are at high risk of post-hepatectomy liver failure (PHLF) and require FLR hypertrophy-inducing procedures to enable safe resection. The most recent variant of these procedures is combined portal and hepatic vein embolization (PVE/HVE). The DRAGON 1 trial evaluates the safety and efficacy of PVE/HVE, while assessing recruitment potential for the DRAGON 2 randomized trial. Methods: DRAGON 1 is a prospective, single-arm, international, multicenter trial. Patients with upfront unresectable CRLM due to a small FLR were included. The primary outcome was the ability of centers to recruit three patients and perform PVE/HVE and liver resection without 90-day mortality. Secondary outcomes included recruitment capacity, PVE/HVE technical details, FLR volume changes, complications, and resection rates. The study is registered at ClinicalTrials.gov, identifier: NCT04272931. Findings: In total, 102 patients were included from 43 centers. Twenty-four centers (24/43 = 56%) recruited three or more patients, and 20 centers (20/43 = 47%) achieved this without 90-day mortality. Of 96 patients undergoing PVE/HVE, no post-embolization mortality occurred, though major complications were reported in two patients. Resection was completed in 86 patients (86/96 = 90%), with seven patients (7/86 = 8%) dying within 90 days. PHLF grade B/C (International Study Group of Liver Surgery criteria) occurred in 19 patients (19/86 = 22%). Interpretation: DRAGON 1 demonstrates that PVE/HVE is safe, with no embolization-related mortality, low morbidity, and high resection rates in upfront unresectable CRLM. Funding: The Dutch Cancer Society, National Institute for Health and Care Research UK, Maastricht UMC+, Abbott Laboratories and Guerbet. |
| format | Article |
| id | doaj-art-27655ba615d54dc3b66a3e55c2f293ea |
| institution | OA Journals |
| issn | 2666-7762 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Regional Health. Europe |
| spelling | doaj-art-27655ba615d54dc3b66a3e55c2f293ea2025-08-20T02:09:25ZengElsevierThe Lancet Regional Health. Europe2666-77622025-06-015310128410.1016/j.lanepe.2025.101284Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trialResearch in contextRemon Korenblik0Sinéad James1Jens Smits2Rafael Díaz-Nieto3Rob Davis4Benjamin K.Y. Chan5Joris I. Erdmann6IJsbrand A.J. Zijlstra7Pieter J.W. Arntz8Otto Kollmar9Martin H. Hoffmann10David G. Vass11Richard Lindsay12Matteo Serenari13Alberto Cappelli14Paul D. Gobardhan15Farshad Imani16Yiliam Fundora Suarez17Fernando Gómez Muños18Dirk J. Grünhagen19Adriaan Moelker20Kay J. Pieterman21Jörg Kleeff22Walter A. Wohlgemuth23Eric Herrero24Arantxa Gelabert25Stefan Breitenstein26Nico Seeger27Olivier Detry28Laurent Gerard29Per A. Sandström30Bergthor Björnsson31Luca A. Aldrighetti32Francesco De Cobelli33Wouter K.G. Leclercq34Laurens J. van Baardewijk35Daniel Croagh36Diederick W. De Boo37T. Peter Kingham38Fourat Ridouani39Peter Metrakos40David Valenti41Jennifer Kalil42Åsmund A. Fretland43Ulrik Carling44Guillaume Martel45Stephen Ryan46Venkatesha Udupa47Andrew Macdonald48Jordan C. Tasse49Gregor A. Stavrou50Elmar Spuentrup51Francisco G. Borobia52Eva Criado53Ernesto Sparrelid54Martin Delle55Jordi Navinés-López56Jaume Sampere Moragues57Esteban Cugat Andorrà58Andreas Schnitzbauer59Thomas J. Vogl60Jan Heil61John N. Primrose62Sachin Modi63Suomi M.G. Fouraschen64Reinoud P.H. Bokkers65Marieke T. de Boer66Inne H.M. Borel Rinkes67Maarten L.J. Smits68Thomas Gruenberger69Ivan Baclija70Kevin G. Billingsley71David C. Madoff72Alejandro Serrablo73Luis Sarriá74Xiaoying Wang75Qu Xudong76Bjorn Winkens77Steven W.L. Olde Damink78Marc H.A. Bemelmans79Maxime J.L. Dewulf80Christoph A. Binkert81Erik Schadde82Christiaan van der Leij83Ronald M. van Dam84M. Abu HilalC. AlomanK. BrousseauR.C.G. BruijnenM. CesconB. ChandJ. Codina FontM. CrawfordS.W. de BoerJ.F. De WispelaereA. DiliM. DixonJ. EngstrandA. Erbahceci SalikS.W. FenwickO. FisherS. GilgF. GiulianteL.F. GrocholaJ. HagendoornM.H. HeijmansG.F. HessR. IezziR. JonesG. KazemierS. KernR.R.M.M. KnapenC. LambrechtS. Lopez-BenV. LucidiD. MacleanH. MalikG. MaleuxM.R. MeijerinkJ. MelenhorstK. MenonD. MurphyB. OlijJ.E. OorS. PappasP. PedduF. RattiM. RavaioliC. RoganU. RonellenfitschS. RossC. SallemiL.A. SahanR.J. SwijnenburgI. TancrediO.M. Van DeldenA.L. van der VeldenM. VandermeulenR. WidyaningsihR. YoungDepartment of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands; GROW School for Oncology and Reproduction, Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, the NetherlandsDepartment of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands; GROW School for Oncology and Reproduction, Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, the NetherlandsDepartment of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands; GROW School for Oncology and Reproduction, Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, the NetherlandsDepartment of Liver Surgery, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UKDepartment of Interventional Radiology, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UKDepartment of Liver Surgery, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UKDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the NetherlandsDepartment of Radiology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the NetherlandsDepartment of Radiology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the NetherlandsDepartment of Surgery, Clarunis University Hospital, Surgery, Kleinriehenstrasse 30, 4058, Basel, SwitzerlandDepartment of Radiology, St. Claraspital, Kleinriehenstrasse 30, 4058, Basel, SwitzerlandDepartment of Surgery, Belfast Health & Social Care Trust, 51 Lisburn Rd, Belfast, BT9 7AB, UKDepartment of Interventional Radiology, Belfast Health & Social Care Trust, 51 Lisburn Rd, Belfast, BT9 7AB, UKHepato-biliary and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni 15, 40138, Bologna, BO, Italy; Department of Medical and Surgical Sciences, University of Bologna, Via Zamboni, 33, 40126, Bologna, BO, ItalyDepartment of Radiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Zamboni, 33, 40126, Bologna, BO, ItalyDepartment of Surgery, Amphia, Molengracht 21, 4818 CK, Breda, the NetherlandsDepartment of Radiology, Amphia Molengracht 21, 4818 CK, Breda, the NetherlandsDepartment of Surgery, Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, SpainDepartment of Radiology, Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, SpainDepartment of Surgery, Erasmus Medisch Centrum, Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the NetherlandsDepartment of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the NetherlandsDepartment of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the NetherlandsDepartment of Surgery, University Hospital Halle (Saale), Ernst-Grube-Straße 40, 06120, Halle, GermanyDepartment of Radiology, University Hospital Halle (Saale), Ernst-Grube-Straße 40, 06120, Halle, GermanyDepartment of Surgery, University Hospital Mútua Terrassa, Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, SpainDepartment of Radiology, Hospital Parc Taulí de Sabadell, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain; Department of Radiology, University Hospital Mútua Terassa, Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, SpainDepartment of Visceral and Thoracic Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, SwitzerlandDepartment of Visceral and Thoracic Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, SwitzerlandDepartment of Abdominal Surgery and Transplantation, University of Liege, CHU Liege, Liege, Avenue de l'Hôpital 1, 4000, Liège, BelgiumDepartment of Radiology, CHU Liege, Liege, Avenue de l'Hôpital 1, 4000, Liège, BelgiumDepartment of Surgery, Linköping University Hospital, Universitetssjukhuset, 581 85, Linköping, SwedenDepartment of Surgery, Linköping University Hospital, Universitetssjukhuset, 581 85, Linköping, SwedenDepartment of Surgery, Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, ItalyDepartment of Radiology, Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, ItalyDepartment of Surgery, Máxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, the NetherlandsDepartment of Radiology, Máxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, the NetherlandsDepartment of Surgery, Monash Health, 246 Clayton Rd, Clayton, VIC, 3168, Australia; Monash University, Melbourne, Wellington Rd, Clayton, VIC, 3800, AustraliaDepartment of Radiology, Monash Health, 246 Clayton Rd, Clayton, VIC, 3168, Australia; Monash University, Melbourne, Wellington Rd, Clayton, VIC, 3800, AustraliaDepartment of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USADepartment of Interventional Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USADepartment of Surgery, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, CanadaDepartment of Radiology, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, CanadaDepartment of Surgery, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, CanadaDepartment of Surgery, Rikshospitalet, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, NorwayDepartment of Radiology, Rikshospitalet, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, NorwayDepartment of Surgery, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, CanadaDepartment of Radiology, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, CanadaDepartment of HPB Surgery, Oxford University Hospitals NHS Foundation Trust, Headley Way, Headington, Oxford, OX3 9DU, UKDepartment of Radiology, Oxford University Hospitals NHS Foundation Trust, Headley Way, Headington, Oxford, OX3 9DU, UKDepartment of Interventional Radiology, Rush University Medical Center, 1620 W Harrison St, Chicago, IL, 60612, USADepartment of General, Visceral and Thoracic Surgery, Surgical Oncology, Klinikum Saarbruecken, Winterberg 1, 66119, Saarbrücken, GermanyInstitute for Diagnostic and Interventional Radiology and Neuroradiology, Klinikum Saarbruecken, Winterberg 1, 66119, Saarbrücken, GermanyDepartment of Surgery, Hospital Parc Taulí de Sabadell, Parc Taulí 1, 08208, Sabadell, Barcelona, SpainInterventional Radiology Unit, UDIAT-Centre Diagnòstic, Hospital Universitario Parc Tauli Sabadell, Medicine Department Universidad Autónoma de Barcelona, Parc Taulí 1, 08208, Sabadell, Barcelona, SpainDivision of Surgery and Oncology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Nobels väg 6, 171 77, Stockholm, SwedenDivision of Radiology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Nobels väg 6, 171 77, Stockholm, SwedenDepartment of Surgery, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, SpainDepartment of Radiology, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, SpainDepartment of Surgery, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, SpainDepartment of Surgery, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, GermanyDepartment of Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, GermanyDepartment of Surgery, University of Ulm, Albert-Einstein-Allee 7, 89081, Ulm, GermanyUniversity Surgery, University Hospital Southampton NHS Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UKDepartment of Radiology, University Hospital Southampton NHS Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UKDepartment of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the NetherlandsDepartment of Radiology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the NetherlandsDepartment of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the NetherlandsDepartment of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the NetherlandsDepartment of Radiology and Nuclear Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the NetherlandsDepartment of Surgery, HPB Center, Clinic Favoriten, Health Network Vienna, Kundratstraße 3, 1100, Wien, Austria; Sigmund Freud University Vienna, Freudplatz 1, 1020, Wien, AustriaDepartment of Radiology, Clinic Favoriten, Kundratstraße 3, 1100, Wien, AustriaDepartment of Surgery, Yale University School of Medicine, 333 Cedar St, New Haven, CT, 06510, USADepartment of Radiology, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USADepartment of Surgery, University Hospital Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, SpainDepartment of Radiology, University Hospital Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, SpainDepartment of Surgery, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Xuhui District, Shanghai, 200032, ChinaDepartment of Radiology, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Xuhui District, Shanghai, 200032, ChinaDepartment of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the NetherlandsDepartment of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the NetherlandsDepartment of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the NetherlandsDepartment of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the NetherlandsClinic of Interventional Radiology and Vascular Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, SwitzerlandDepartment of Surgery, Rush University Medical Center, 1620 W Harrison St, Chicago, IL, 60612, USA; Chirurgie Zentrum, Hirslanden Klinik, St. Anna Luzern, St. Anna-Strasse 32, 6006, Luzern, SwitzerlandGROW School for Oncology and Reproduction, Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, the Netherlands; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX, Maastricht, the NetherlandsDepartment of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands; GROW School for Oncology and Reproduction, Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, the Netherlands; Corresponding author. Department of Surgery, Maastricht UMC+, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.Summary: Background: Major liver resection is often required for complete clearance of colorectal liver metastases (CRLM). Patients with insufficient future liver remnant (FLR) volume/function are at high risk of post-hepatectomy liver failure (PHLF) and require FLR hypertrophy-inducing procedures to enable safe resection. The most recent variant of these procedures is combined portal and hepatic vein embolization (PVE/HVE). The DRAGON 1 trial evaluates the safety and efficacy of PVE/HVE, while assessing recruitment potential for the DRAGON 2 randomized trial. Methods: DRAGON 1 is a prospective, single-arm, international, multicenter trial. Patients with upfront unresectable CRLM due to a small FLR were included. The primary outcome was the ability of centers to recruit three patients and perform PVE/HVE and liver resection without 90-day mortality. Secondary outcomes included recruitment capacity, PVE/HVE technical details, FLR volume changes, complications, and resection rates. The study is registered at ClinicalTrials.gov, identifier: NCT04272931. Findings: In total, 102 patients were included from 43 centers. Twenty-four centers (24/43 = 56%) recruited three or more patients, and 20 centers (20/43 = 47%) achieved this without 90-day mortality. Of 96 patients undergoing PVE/HVE, no post-embolization mortality occurred, though major complications were reported in two patients. Resection was completed in 86 patients (86/96 = 90%), with seven patients (7/86 = 8%) dying within 90 days. PHLF grade B/C (International Study Group of Liver Surgery criteria) occurred in 19 patients (19/86 = 22%). Interpretation: DRAGON 1 demonstrates that PVE/HVE is safe, with no embolization-related mortality, low morbidity, and high resection rates in upfront unresectable CRLM. Funding: The Dutch Cancer Society, National Institute for Health and Care Research UK, Maastricht UMC+, Abbott Laboratories and Guerbet.http://www.sciencedirect.com/science/article/pii/S2666776225000766Portal vein embolizationHepatic vein embolizationLiver venous deprivationColorectal liver metastasesFuture liver remnantLiver resection |
| spellingShingle | Remon Korenblik Sinéad James Jens Smits Rafael Díaz-Nieto Rob Davis Benjamin K.Y. Chan Joris I. Erdmann IJsbrand A.J. Zijlstra Pieter J.W. Arntz Otto Kollmar Martin H. Hoffmann David G. Vass Richard Lindsay Matteo Serenari Alberto Cappelli Paul D. Gobardhan Farshad Imani Yiliam Fundora Suarez Fernando Gómez Muños Dirk J. Grünhagen Adriaan Moelker Kay J. Pieterman Jörg Kleeff Walter A. Wohlgemuth Eric Herrero Arantxa Gelabert Stefan Breitenstein Nico Seeger Olivier Detry Laurent Gerard Per A. Sandström Bergthor Björnsson Luca A. Aldrighetti Francesco De Cobelli Wouter K.G. Leclercq Laurens J. van Baardewijk Daniel Croagh Diederick W. De Boo T. Peter Kingham Fourat Ridouani Peter Metrakos David Valenti Jennifer Kalil Åsmund A. Fretland Ulrik Carling Guillaume Martel Stephen Ryan Venkatesha Udupa Andrew Macdonald Jordan C. Tasse Gregor A. Stavrou Elmar Spuentrup Francisco G. Borobia Eva Criado Ernesto Sparrelid Martin Delle Jordi Navinés-López Jaume Sampere Moragues Esteban Cugat Andorrà Andreas Schnitzbauer Thomas J. Vogl Jan Heil John N. Primrose Sachin Modi Suomi M.G. Fouraschen Reinoud P.H. Bokkers Marieke T. de Boer Inne H.M. Borel Rinkes Maarten L.J. Smits Thomas Gruenberger Ivan Baclija Kevin G. Billingsley David C. Madoff Alejandro Serrablo Luis Sarriá Xiaoying Wang Qu Xudong Bjorn Winkens Steven W.L. Olde Damink Marc H.A. Bemelmans Maxime J.L. Dewulf Christoph A. Binkert Erik Schadde Christiaan van der Leij Ronald M. van Dam M. Abu Hilal C. Aloman K. Brousseau R.C.G. Bruijnen M. Cescon B. Chand J. Codina Font M. Crawford S.W. de Boer J.F. De Wispelaere A. Dili M. Dixon J. Engstrand A. Erbahceci Salik S.W. Fenwick O. Fisher S. Gilg F. Giuliante L.F. Grochola J. Hagendoorn M.H. Heijmans G.F. Hess R. Iezzi R. Jones G. Kazemier S. Kern R.R.M.M. Knapen C. Lambrecht S. Lopez-Ben V. Lucidi D. Maclean H. Malik G. Maleux M.R. Meijerink J. Melenhorst K. Menon D. Murphy B. Olij J.E. Oor S. Pappas P. Peddu F. Ratti M. Ravaioli C. Rogan U. Ronellenfitsch S. Ross C. Sallemi L.A. Sahan R.J. Swijnenburg I. Tancredi O.M. Van Delden A.L. van der Velden M. Vandermeulen R. Widyaningsih R. Young Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trialResearch in context The Lancet Regional Health. Europe Portal vein embolization Hepatic vein embolization Liver venous deprivation Colorectal liver metastases Future liver remnant Liver resection |
| title | Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trialResearch in context |
| title_full | Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trialResearch in context |
| title_fullStr | Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trialResearch in context |
| title_full_unstemmed | Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trialResearch in context |
| title_short | Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trialResearch in context |
| title_sort | safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases dragon1 a multicentre single arm clinical trialresearch in context |
| topic | Portal vein embolization Hepatic vein embolization Liver venous deprivation Colorectal liver metastases Future liver remnant Liver resection |
| url | http://www.sciencedirect.com/science/article/pii/S2666776225000766 |
| work_keys_str_mv | AT remonkorenblik safetyandefficacyofcombinedportalandhepaticveinembolisationinpatientswithcolorectallivermetastasesdragon1amulticentresinglearmclinicaltrialresearchincontext AT sineadjames safetyandefficacyofcombinedportalandhepaticveinembolisationinpatientswithcolorectallivermetastasesdragon1amulticentresinglearmclinicaltrialresearchincontext AT jenssmits safetyandefficacyofcombinedportalandhepaticveinembolisationinpatientswithcolorectallivermetastasesdragon1amulticentresinglearmclinicaltrialresearchincontext AT rafaeldiaznieto safetyandefficacyofcombinedportalandhepaticveinembolisationinpatientswithcolorectallivermetastasesdragon1amulticentresinglearmclinicaltrialresearchincontext AT robdavis safetyandefficacyofcombinedportalandhepaticveinembolisationinpatientswithcolorectallivermetastasesdragon1amulticentresinglearmclinicaltrialresearchincontext AT benjaminkychan 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safetyandefficacyofcombinedportalandhepaticveinembolisationinpatientswithcolorectallivermetastasesdragon1amulticentresinglearmclinicaltrialresearchincontext AT rwidyaningsih safetyandefficacyofcombinedportalandhepaticveinembolisationinpatientswithcolorectallivermetastasesdragon1amulticentresinglearmclinicaltrialresearchincontext AT ryoung safetyandefficacyofcombinedportalandhepaticveinembolisationinpatientswithcolorectallivermetastasesdragon1amulticentresinglearmclinicaltrialresearchincontext |