Article (Scientific journals)
Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial.
Korenblik, Remon; James, Sinéad; Smits, Jens et al.
2025In The Lancet Regional Health. Europe, 53, p. 101284
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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; Internal Medicine; Oncology; Health Policy
Abstract :
[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
DRAGON collaborative study group
More authors (76 more) Less
Language :
English
Title :
Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial.
Publication date :
June 2025
Journal title :
The Lancet Regional Health. Europe
eISSN :
2666-7762
Publisher :
Elsevier, England
Volume :
53
Pages :
101284
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
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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