Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial. - 2025
Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial.
[en] [en] 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.
Disciplines :
Surgery
Author, co-author :
Korenblik, Remon ; Department 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
James, Sinéad ; Department 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
Smits, Jens; Department 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
Díaz-Nieto, Rafael; Department of Liver Surgery, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UK
Davis, Rob; Department of Interventional Radiology, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UK
Chan, Benjamin K Y; Department of Liver Surgery, Liverpool University Hospitals NHS, Lower Ln, Fazakerley, Liverpool, L9 7AL, UK
Erdmann, Joris I; Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands
Zijlstra, IJsbrand A J; Department of Radiology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands
Arntz, Pieter J W; Department of Radiology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands
Kollmar, Otto; Department of Surgery, Clarunis University Hospital, Surgery, Kleinriehenstrasse 30, 4058, Basel, Switzerland
Hoffmann, Martin H; Department of Radiology, St. Claraspital, Kleinriehenstrasse 30, 4058, Basel, Switzerland
Vass, David G; Department of Surgery, Belfast Health & Social Care Trust, 51 Lisburn Rd, Belfast, BT9 7AB, UK
Lindsay, Richard; Department of Interventional Radiology, Belfast Health & Social Care Trust, 51 Lisburn Rd, Belfast, BT9 7AB, UK
Serenari, Matteo; Hepato-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, Italy
Cappelli, Alberto; Department of Radiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Via Zamboni, 33, 40126, Bologna, BO, Italy
Gobardhan, Paul D; Department of Surgery, Amphia, Molengracht 21, 4818 CK, Breda, the Netherlands
Imani, Farshad; Department of Radiology, Amphia Molengracht 21, 4818 CK, Breda, the Netherlands
Suarez, Yiliam Fundora ; Department of Surgery, Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain
Muños, Fernando Gómez; Department of Radiology, Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain
Grünhagen, Dirk J; Department of Surgery, Erasmus Medisch Centrum, Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands
Moelker, Adriaan; Department of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands
Pieterman, Kay J; Department of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands
Kleeff, Jörg; Department of Surgery, University Hospital Halle (Saale), Ernst-Grube-Straße 40, 06120, Halle, Germany
Wohlgemuth, Walter A; Department of Radiology, University Hospital Halle (Saale), Ernst-Grube-Straße 40, 06120, Halle, Germany
Herrero, Eric; Department of Surgery, University Hospital Mútua Terrassa, Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain
Gelabert, Arantxa ; Department 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, Spain
Breitenstein, Stefan; Department of Visceral and Thoracic Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, Switzerland
Seeger, Nico ; Department of Visceral and Thoracic Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, Switzerland
Detry, Olivier ; Université de Liège - ULiège > Département des sciences cliniques > Pathologie chirurgicale abdominale et endocrinienne
GERARD, Laurent ; Centre Hospitalier Universitaire de Liège - CHU > > Service médical de radiodiagnostic
Sandström, Per A; Department of Surgery, Linköping University Hospital, Universitetssjukhuset, 581 85, Linköping, Sweden
Björnsson, Bergthor; Department of Surgery, Linköping University Hospital, Universitetssjukhuset, 581 85, Linköping, Sweden
Aldrighetti, Luca A; Department of Surgery, Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy
De Cobelli, Francesco; Department of Radiology, Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy
Leclercq, Wouter K G ; Department of Surgery, Máxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, the Netherlands
van Baardewijk, Laurens J; Department of Radiology, Máxima Medisch Centrum, De Run 4600, 5504 DB, Veldhoven, the Netherlands
Croagh, Daniel ; Department of Surgery, Monash Health, 246 Clayton Rd, Clayton, VIC, 3168, Australia ; Monash University, Melbourne, Wellington Rd, Clayton, VIC, 3800, Australia
De Boo, Diederick W; Department of Radiology, Monash Health, 246 Clayton Rd, Clayton, VIC, 3168, Australia ; Monash University, Melbourne, Wellington Rd, Clayton, VIC, 3800, Australia
Kingham, T Peter; Department of Surgery, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA
Ridouani, Fourat; Department of Interventional Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA
Metrakos, Peter; Department of Surgery, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada
Valenti, David; Department of Radiology, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada
Kalil, Jennifer ; Department of Surgery, McGill University Health Centre, 1001 Decarie Blvd, Montreal, QC, H4A 3J1, Canada
Fretland, Åsmund A; Department of Surgery, Rikshospitalet, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, Norway
Carling, Ulrik; Department of Radiology, Rikshospitalet, Oslo University Hospital, Sognsvannsveien 20, 0372, Oslo, Norway
Martel, Guillaume; Department of Surgery, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada
Ryan, Stephen; Department of Radiology, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada
Udupa, Venkatesha; Department of HPB Surgery, Oxford University Hospitals NHS Foundation Trust, Headley Way, Headington, Oxford, OX3 9DU, UK
Macdonald, Andrew; Department of Radiology, Oxford University Hospitals NHS Foundation Trust, Headley Way, Headington, Oxford, OX3 9DU, UK
Tasse, Jordan C; Department of Interventional Radiology, Rush University Medical Center, 1620 W Harrison St, Chicago, IL, 60612, USA
Stavrou, Gregor A ; Department of General, Visceral and Thoracic Surgery, Surgical Oncology, Klinikum Saarbruecken, Winterberg 1, 66119, Saarbrücken, Germany
Spuentrup, Elmar; Institute for Diagnostic and Interventional Radiology and Neuroradiology, Klinikum Saarbruecken, Winterberg 1, 66119, Saarbrücken, Germany
Borobia, Francisco G; Department of Surgery, Hospital Parc Taulí de Sabadell, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain
Criado, Eva; Interventional Radiology Unit, UDIAT-Centre Diagnòstic, Hospital Universitario Parc Tauli Sabadell, Medicine Department Universidad Autónoma de Barcelona, Parc Taulí 1, 08208, Sabadell, Barcelona, Spain
Sparrelid, Ernesto; Division of Surgery and Oncology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Nobels väg 6, 171 77, Stockholm, Sweden
Delle, Martin; Division of Radiology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Karolinska University Hospital, Nobels väg 6, 171 77, Stockholm, Sweden
Navinés-López, Jordi; Department of Surgery, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, Spain
Moragues, Jaume Sampere; Department of Radiology, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, Spain
Andorrà, Esteban Cugat; Department of Surgery, University Hospital Germans Trias I Pujol, Ctra. de Canyet, s/n, 08916, Badalona, Barcelona, Spain
Schnitzbauer, Andreas; Department of Surgery, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany
Vogl, Thomas J; Department of Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany
Heil, Jan; Department of Surgery, University of Ulm, Albert-Einstein-Allee 7, 89081, Ulm, Germany
Primrose, John N; University Surgery, University Hospital Southampton NHS Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UK
Modi, Sachin; Department of Radiology, University Hospital Southampton NHS Trust, Tremona Road, Southampton, Hampshire, SO16 6YD, UK
Fouraschen, Suomi M G; Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands
Bokkers, Reinoud P H; Department of Radiology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands
de Boer, Marieke T; Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, the Netherlands
Borel Rinkes, Inne H M; Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands
Smits, Maarten L J; Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands
Gruenberger, Thomas; Department of Surgery, HPB Center, Clinic Favoriten, Health Network Vienna, Kundratstraße 3, 1100, Wien, Austria ; Sigmund Freud University Vienna, Freudplatz 1, 1020, Wien, Austria
Baclija, Ivan; Department of Radiology, Clinic Favoriten, Kundratstraße 3, 1100, Wien, Austria
Billingsley, Kevin G; Department of Surgery, Yale University School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA
Madoff, David C; Department of Radiology, Yale School of Medicine, 333 Cedar St, New Haven, CT, 06510, USA
Serrablo, Alejandro; Department of Surgery, University Hospital Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain
Sarriá, Luis; Department of Radiology, University Hospital Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain
Wang, Xiaoying; Department of Surgery, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Xuhui District, Shanghai, 200032, China
Xudong, Qu; Department of Radiology, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Xuhui District, Shanghai, 200032, China
Winkens, Bjorn; Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands
Olde Damink, Steven W L; Department of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands
Bemelmans, Marc H A; Department of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands
Dewulf, Maxime J L; Department of Surgery, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands
Binkert, Christoph A; Clinic of Interventional Radiology and Vascular Surgery, Kantonsspital Winterthur, Brauerstrasse 15, 8400, Winterthur, Switzerland
Schadde, Erik; Department 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, Switzerland
van der Leij, Christiaan; GROW 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 Netherlands
van Dam, Ronald M; Department 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
Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial.
CIHR - Canadian Institutes of Health Research CBS - Canadian Blood Services
Funding text :
The Dutch Cancer Society, National Institute for Health and Care Research UK, Maastricht UMC+, Abbott Laboratories and Guerbet.C.A. Binkert: research support from Abbott Laboratories; consulting fees from CTI Vascular, Biotronic (consulting on technology). \u00C5.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.
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