. 2025 Apr 10:53:101284.

doi: 10.1016/j.lanepe.2025.101284. eCollection 2025 Jun.

Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial

Remon Korenblik^{1

2}, Sinéad James^{1

2}, Jens Smits^{1

2}, Rafael Díaz-Nieto³, Rob Davis⁴, Benjamin K Y Chan³, Joris I Erdmann⁵, IJsbrand A J Zijlstra⁶, Pieter J W Arntz⁶, Otto Kollmar⁷, Martin H Hoffmann⁸, David G Vass⁹, Richard Lindsay¹⁰, Matteo Serenari^{11

12}, Alberto Cappelli¹³, Paul D Gobardhan¹⁴, Farshad Imani¹⁵, Yiliam Fundora Suarez¹⁶, Fernando Gómez Muños¹⁷, Dirk J Grünhagen¹⁸, Adriaan Moelker¹⁹, Kay J Pieterman¹⁹, Jörg Kleeff²⁰, Walter A Wohlgemuth²¹, Eric Herrero²², Arantxa Gelabert^{23

24}, Stefan Breitenstein²⁵, Nico Seeger²⁵, Olivier Detry²⁶, Laurent Gerard²⁷, Per A Sandström²⁸, Bergthor Björnsson²⁸, Luca A Aldrighetti²⁹, Francesco De Cobelli³⁰, Wouter K G Leclercq³¹, Laurens J van Baardewijk³², Daniel Croagh^{33

34}, Diederick W De Boo^{35

34}, T Peter Kingham³⁶, Fourat Ridouani³⁷, Peter Metrakos³⁸, David Valenti³⁹, Jennifer Kalil³⁸, Åsmund A Fretland⁴⁰, Ulrik Carling⁴¹, Guillaume Martel⁴², Stephen Ryan⁴³, Venkatesha Udupa⁴⁴, Andrew Macdonald⁴⁵, Jordan C Tasse⁴⁶, Gregor A Stavrou⁴⁷, Elmar Spuentrup⁴⁸, Francisco G Borobia⁴⁹, Eva Criado⁵⁰, Ernesto Sparrelid⁵¹, Martin Delle⁵², Jordi Navinés-López⁵³, Jaume Sampere Moragues⁵⁴, Esteban Cugat Andorrà⁵³, Andreas Schnitzbauer⁵⁵, Thomas J Vogl⁵⁶, Jan Heil⁵⁷, John N Primrose⁵⁸, Sachin Modi⁵⁹, Suomi M G Fouraschen⁶⁰, Reinoud P H Bokkers⁶¹, Marieke T de Boer⁶⁰, Inne H M Borel Rinkes⁶², Maarten L J Smits⁶³, Thomas Gruenberger^{64

65}, Ivan Baclija⁶⁶, Kevin G Billingsley⁶⁷, David C Madoff⁶⁸, Alejandro Serrablo⁶⁹, Luis Sarriá⁷⁰, Xiaoying Wang⁷¹, Qu Xudong⁷², Bjorn Winkens⁷³, Steven W L Olde Damink¹, Marc H A Bemelmans¹, Maxime J L Dewulf¹, Christoph A Binkert⁷⁴, Erik Schadde^{75

76}, Christiaan van der Leij^{2

77}, Ronald M van Dam^{1

2}; DRAGON collaborative study group

Collaborators, Affiliations

Collaborators

DRAGON collaborative study group:
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

Affiliations

¹ Department of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands.
² GROW School for Oncology and Reproduction, Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, the Netherlands.
³ Department of Liver Surgery, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UK.
⁴ Department of Interventional Radiology, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UK.
⁵ Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
⁶ Department of Radiology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
⁷ Department of Surgery, Clarunis University Hospital, Surgery, Kleinriehenstrasse 30, 4058, Basel, Switzerland.
⁸ Department of Radiology, St. Claraspital, Kleinriehenstrasse 30, 4058, Basel, Switzerland.
⁹ Department of Surgery, Belfast Health & Social Care Trust, 51 Lisburn Rd, Belfast, BT9 7AB, UK.
¹⁰ Department of Interventional Radiology, Belfast Health & Social Care Trust, 51 Lisburn Rd, Belfast, BT9 7AB, UK.
¹¹ Hepato-biliary and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni 15, 40138, Bologna, BO, Italy.
¹² Department of Medical and Surgical Sciences, University of Bologna, Via Zamboni, 33, 40126, Bologna, BO, Italy.
¹³ Department of Radiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Zamboni, 33, 40126, Bologna, BO, Italy.
¹⁴ Department of Surgery, Amphia, Molengracht 21, 4818 CK, Breda, the Netherlands.
¹⁵ Department of Radiology, Amphia Molengracht 21, 4818 CK, Breda, the Netherlands.
¹⁶ Department of Surgery, Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain.
¹⁷ Department of Radiology, Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain.
¹⁸ Department of Surgery, Erasmus Medisch Centrum, Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.
¹⁹ Department of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.
²⁰ Department of Surgery, University Hospital Halle (Saale), Ernst-Grube-Straße 40, 06120, Halle, Germany.
²¹ Department of Radiology, University Hospital Halle (Saale), Ernst-Grube-Straße 40, 06120, Halle, Germany.
²² Department of Surgery, University Hospital Mútua Terrassa, Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain.
²³ Department of Radiology, Hospital Parc Taulí de Sabadell, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain.
²⁴ Department of Radiology, University Hospital Mútua Terassa, Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain.
²⁵ Department of Visceral and Thoracic Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, Switzerland.
²⁶ Department of Abdominal Surgery and Transplantation, University of Liege, CHU Liege, Liege, Avenue de l'Hôpital 1, 4000, Liège, Belgium.
²⁷ Department of Radiology, CHU Liege, Liege, Avenue de l'Hôpital 1, 4000, Liège, Belgium.
²⁸ Department of Surgery, Linköping University Hospital, Universitetssjukhuset, 581 85, Linköping, Sweden.
²⁹ Department of Surgery, Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
³⁰ Department of Radiology, Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
³¹ Department of Surgery, Máxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, the Netherlands.
³² Department of Radiology, Máxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, the Netherlands.
³³ Department of Surgery, Monash Health, 246 Clayton Rd, Clayton, VIC, 3168, Australia.
³⁴ Monash University, Melbourne, Wellington Rd, Clayton, VIC, 3800, Australia.
³⁵ Department of Radiology, Monash Health, 246 Clayton Rd, Clayton, VIC, 3168, Australia.
³⁶ Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA.
³⁷ Department of Interventional Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA.
³⁸ Department of Surgery, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada.
³⁹ Department of Radiology, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada.
⁴⁰ Department of Surgery, Rikshospitalet, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, Norway.
⁴¹ Department of Radiology, Rikshospitalet, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, Norway.
⁴² Department of Surgery, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
⁴³ Department of Radiology, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
⁴⁴ Department of HPB Surgery, Oxford University Hospitals NHS Foundation Trust, Headley Way, Headington, Oxford, OX3 9DU, UK.
⁴⁵ Department of Radiology, Oxford University Hospitals NHS Foundation Trust, Headley Way, Headington, Oxford, OX3 9DU, UK.
⁴⁶ Department of Interventional Radiology, Rush University Medical Center, 1620 W Harrison St, Chicago, IL, 60612, USA.
⁴⁷ Department of General, Visceral and Thoracic Surgery, Surgical Oncology, Klinikum Saarbruecken, Winterberg 1, 66119, Saarbrücken, Germany.
⁴⁸ Institute for Diagnostic and Interventional Radiology and Neuroradiology, Klinikum Saarbruecken, Winterberg 1, 66119, Saarbrücken, Germany.
⁴⁹ Department of Surgery, Hospital Parc Taulí de Sabadell, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain.
⁵⁰ Interventional Radiology Unit, UDIAT-Centre Diagnòstic, Hospital Universitario Parc Tauli Sabadell, Medicine Department Universidad Autónoma de Barcelona, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain.
⁵¹ Division of Surgery and Oncology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Nobels väg 6, 171 77, Stockholm, Sweden.
⁵² Division of Radiology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Nobels väg 6, 171 77, Stockholm, Sweden.
⁵³ Department of Surgery, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, Spain.
⁵⁴ Department of Radiology, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, Spain.
⁵⁵ Department of Surgery, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany.
⁵⁶ Department of Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany.
⁵⁷ Department of Surgery, University of Ulm, Albert-Einstein-Allee 7, 89081, Ulm, Germany.
⁵⁸ University Surgery, University Hospital Southampton NHS Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UK.
⁵⁹ Department of Radiology, University Hospital Southampton NHS Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UK.
⁶⁰ Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.
⁶¹ Department of Radiology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.
⁶² Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
⁶³ Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
⁶⁴ Department of Surgery, HPB Center, Clinic Favoriten, Health Network Vienna, Kundratstraße 3, 1100, Wien, Austria.
⁶⁵ Sigmund Freud University Vienna, Freudplatz 1, 1020, Wien, Austria.
⁶⁶ Department of Radiology, Clinic Favoriten, Kundratstraße 3, 1100, Wien, Austria.
⁶⁷ Department of Surgery, Yale University School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
⁶⁸ Department of Radiology, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
⁶⁹ Department of Surgery, University Hospital Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
⁷⁰ Department of Radiology, University Hospital Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
⁷¹ Department of Surgery, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Xuhui District, Shanghai, 200032, China.
⁷² Department of Radiology, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Xuhui District, Shanghai, 200032, China.
⁷³ Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.
⁷⁴ Clinic of Interventional Radiology and Vascular Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, Switzerland.
⁷⁵ Department of Surgery, Rush University Medical Center, 1620 W Harrison St, Chicago, IL, 60612, USA.
⁷⁶ Chirurgie Zentrum, Hirslanden Klinik, St. Anna Luzern, St. Anna-Strasse 32, 6006, Luzern, Switzerland.
⁷⁷ Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands.

PMID: 40255933
PMCID: PMC12008670
DOI: 10.1016/j.lanepe.2025.101284

Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial

Remon Korenblik et al. Lancet Reg Health Eur. 2025.

. 2025 Apr 10:53:101284.

doi: 10.1016/j.lanepe.2025.101284. eCollection 2025 Jun.

Authors

Collaborators

DRAGON collaborative study group:
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

Affiliations

¹ Department of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands.
² GROW School for Oncology and Reproduction, Maastricht University, Universiteitssingel 40, 6229 ER, Maastricht, the Netherlands.
³ Department of Liver Surgery, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UK.
⁴ Department of Interventional Radiology, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UK.
⁵ Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
⁶ Department of Radiology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
⁷ Department of Surgery, Clarunis University Hospital, Surgery, Kleinriehenstrasse 30, 4058, Basel, Switzerland.
⁸ Department of Radiology, St. Claraspital, Kleinriehenstrasse 30, 4058, Basel, Switzerland.
⁹ Department of Surgery, Belfast Health & Social Care Trust, 51 Lisburn Rd, Belfast, BT9 7AB, UK.
¹⁰ Department of Interventional Radiology, Belfast Health & Social Care Trust, 51 Lisburn Rd, Belfast, BT9 7AB, UK.
¹¹ Hepato-biliary and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni 15, 40138, Bologna, BO, Italy.
¹² Department of Medical and Surgical Sciences, University of Bologna, Via Zamboni, 33, 40126, Bologna, BO, Italy.
¹³ Department of Radiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Zamboni, 33, 40126, Bologna, BO, Italy.
¹⁴ Department of Surgery, Amphia, Molengracht 21, 4818 CK, Breda, the Netherlands.
¹⁵ Department of Radiology, Amphia Molengracht 21, 4818 CK, Breda, the Netherlands.
¹⁶ Department of Surgery, Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain.
¹⁷ Department of Radiology, Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain.
¹⁸ Department of Surgery, Erasmus Medisch Centrum, Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.
¹⁹ Department of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.
²⁰ Department of Surgery, University Hospital Halle (Saale), Ernst-Grube-Straße 40, 06120, Halle, Germany.
²¹ Department of Radiology, University Hospital Halle (Saale), Ernst-Grube-Straße 40, 06120, Halle, Germany.
²² Department of Surgery, University Hospital Mútua Terrassa, Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain.
²³ Department of Radiology, Hospital Parc Taulí de Sabadell, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain.
²⁴ Department of Radiology, University Hospital Mútua Terassa, Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain.
²⁵ Department of Visceral and Thoracic Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, Switzerland.
²⁶ Department of Abdominal Surgery and Transplantation, University of Liege, CHU Liege, Liege, Avenue de l'Hôpital 1, 4000, Liège, Belgium.
²⁷ Department of Radiology, CHU Liege, Liege, Avenue de l'Hôpital 1, 4000, Liège, Belgium.
²⁸ Department of Surgery, Linköping University Hospital, Universitetssjukhuset, 581 85, Linköping, Sweden.
²⁹ Department of Surgery, Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
³⁰ Department of Radiology, Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy.
³¹ Department of Surgery, Máxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, the Netherlands.
³² Department of Radiology, Máxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, the Netherlands.
³³ Department of Surgery, Monash Health, 246 Clayton Rd, Clayton, VIC, 3168, Australia.
³⁴ Monash University, Melbourne, Wellington Rd, Clayton, VIC, 3800, Australia.
³⁵ Department of Radiology, Monash Health, 246 Clayton Rd, Clayton, VIC, 3168, Australia.
³⁶ Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA.
³⁷ Department of Interventional Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA.
³⁸ Department of Surgery, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada.
³⁹ Department of Radiology, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada.
⁴⁰ Department of Surgery, Rikshospitalet, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, Norway.
⁴¹ Department of Radiology, Rikshospitalet, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, Norway.
⁴² Department of Surgery, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
⁴³ Department of Radiology, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
⁴⁴ Department of HPB Surgery, Oxford University Hospitals NHS Foundation Trust, Headley Way, Headington, Oxford, OX3 9DU, UK.
⁴⁵ Department of Radiology, Oxford University Hospitals NHS Foundation Trust, Headley Way, Headington, Oxford, OX3 9DU, UK.
⁴⁶ Department of Interventional Radiology, Rush University Medical Center, 1620 W Harrison St, Chicago, IL, 60612, USA.
⁴⁷ Department of General, Visceral and Thoracic Surgery, Surgical Oncology, Klinikum Saarbruecken, Winterberg 1, 66119, Saarbrücken, Germany.
⁴⁸ Institute for Diagnostic and Interventional Radiology and Neuroradiology, Klinikum Saarbruecken, Winterberg 1, 66119, Saarbrücken, Germany.
⁴⁹ Department of Surgery, Hospital Parc Taulí de Sabadell, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain.
⁵⁰ Interventional Radiology Unit, UDIAT-Centre Diagnòstic, Hospital Universitario Parc Tauli Sabadell, Medicine Department Universidad Autónoma de Barcelona, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain.
⁵¹ Division of Surgery and Oncology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Nobels väg 6, 171 77, Stockholm, Sweden.
⁵² Division of Radiology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Nobels väg 6, 171 77, Stockholm, Sweden.
⁵³ Department of Surgery, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, Spain.
⁵⁴ Department of Radiology, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, Spain.
⁵⁵ Department of Surgery, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany.
⁵⁶ Department of Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany.
⁵⁷ Department of Surgery, University of Ulm, Albert-Einstein-Allee 7, 89081, Ulm, Germany.
⁵⁸ University Surgery, University Hospital Southampton NHS Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UK.
⁵⁹ Department of Radiology, University Hospital Southampton NHS Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UK.
⁶⁰ Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.
⁶¹ Department of Radiology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands.
⁶² Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
⁶³ Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands.
⁶⁴ Department of Surgery, HPB Center, Clinic Favoriten, Health Network Vienna, Kundratstraße 3, 1100, Wien, Austria.
⁶⁵ Sigmund Freud University Vienna, Freudplatz 1, 1020, Wien, Austria.
⁶⁶ Department of Radiology, Clinic Favoriten, Kundratstraße 3, 1100, Wien, Austria.
⁶⁷ Department of Surgery, Yale University School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
⁶⁸ Department of Radiology, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA.
⁶⁹ Department of Surgery, University Hospital Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
⁷⁰ Department of Radiology, University Hospital Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
⁷¹ Department of Surgery, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Xuhui District, Shanghai, 200032, China.
⁷² Department of Radiology, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Xuhui District, Shanghai, 200032, China.
⁷³ Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.
⁷⁴ Clinic of Interventional Radiology and Vascular Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, Switzerland.
⁷⁵ Department of Surgery, Rush University Medical Center, 1620 W Harrison St, Chicago, IL, 60612, USA.
⁷⁶ Chirurgie Zentrum, Hirslanden Klinik, St. Anna Luzern, St. Anna-Strasse 32, 6006, Luzern, Switzerland.
⁷⁷ Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands.

PMID: 40255933
PMCID: PMC12008670
DOI: 10.1016/j.lanepe.2025.101284

Abstract

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.

Keywords: Bilobar colorectal liver metastases; Colorectal liver metastases; DRAGON 1 trial; Embolization techniques; Extended liver resection; FLR hypertrophy; Future liver remnant; Hepatic regeneration; Hepatic vein embolization; Kinetic growth rate; Liver resection; Liver surgery complications; Liver venous deprivation; Multicenter clinical trial; Portal vein embolization; Post-hepatectomy liver failure; Preoperative liver augmentation; Regenerative liver procedures; Resection rates; Surgical oncology.

PubMed Disclaimer

Conflict of interest statement

C.A. Binkert: research support from Abbott Laboratories; consulting fees from CTI Vascular, Biotronic (consulting on technology). Å.A. Fretland: honoraria from Bayer, Angiodynamics, Medtronic (speaker). D.C. Madoff: Receipt of equipment from Abbott Laboratories (plugs), Guerbet (lipiodol), Boston Scientific (embolic particles) for pre-clinical animal studies; consulting fees from Guerbet, Boston Scientific (advisory board). G. Martel: unrelated research grants from Canadian Institutes of Health Research, Canadian Blood Services. R.M. van Dam: research grants and study materials from Abbott Laboratories, Guerbet.

Figures

**Fig. 1**
Flow diagram of patients included. Footnote: FLR: future liver remnant; PVE/HVE: combined portal and hepatic vein embolization.

**Fig. 2**
Volume kinetics. Footnote: Changes in standardized FLR (sFLR%) after combined portal and hepatic vein embolization (PVE/HVE). a. Volume kinetics of all 96 patients that underwent PVE/HVE; b. Volume kinetics of the 70 remaining patients not yet planned for resection at week 3, the 26 patients that were planned for resection after week 1 are excluded; c. Volume kinetics of the 24 remaining patients not yet planned for resection at week 6, the additional 46 patients that were planned for resection after week 3 are also excluded.

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References

1. Regimbeau J.M., Cosse C., Kaiser G., et al. Feasibility, safety and efficacy of two-stage hepatectomy for bilobar liver metastases of colorectal cancer: a LiverMetSurvey analysis. HPB (Oxford) 2017;19(5):396–405. - PubMed
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Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial

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Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial

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