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

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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Main Authors: 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
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:The Lancet Regional Health. Europe
Subjects:
Portal vein embolization
Hepatic vein embolization
Liver venous deprivation
Colorectal liver metastases
Future liver remnant
Liver resection
Online Access:http://www.sciencedirect.com/science/article/pii/S2666776225000766
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Summary: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.
ISSN:2666-7762

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