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

作者：Remon Korenblik, Sinéad James, Jens Smits, Rafael Díaz-Nieto, Rob Davis, Benjamin K. Chan, Joris I. Erdmann, IJsbrand A.J. Zijlstra, Pieter Arntz, Otto Kollmar, Martin H K Hoffmann, David G. Vass, Richard J. Lindsay, Matteo Serenari, Alberto Cappelli, Paul D. Gobardhan, Farshad Imani, Yiliam Fundora, Fernando Gómez Muños, Dirk Jan Grünhagen, Adriaan D. Moelker, Kay J. Pieterman, Jorg H. Kleeff, Walter Alexander Wohlgemuth, Eric Herrero, Arantxa Gelabert, Stefan Breitenstein, Nico Seeger, Olivier Detry, Laurent Gérard, Per Sandström, Bergþór Björnsson, Luca Antonio Aldrighetti, Francesco De Cobelli, Wouter K. G. Leclercq, Laurens J. van Baardewijk, Daniel Gerald Croagh, Diederick Willem De Boo, T. Peter Kingham, Fourat Ridouani, Peter P. Metrakos, David A. Valenti, Jennifer A. Kalil, Åsmund Avdem Fretland, Ulrik Carling, Guillaume Martel, Stephen E. Ryan, Venkatesha Udupa, Andrew Macdonald, Jordan Tasse, Gregor Alexander Stavrou, Elmar Spuentrup, Francisco Garcia Borobia, Eva Criado, Ernesto Sparrelid, Martin Delle, Jordi Navinés-López, Jaume Sampere Moragues, Esteban Cugat Andorrà, Andreas Anton 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 Sarría, Xiaoying Wang, Qu Xudong, Björn 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 · 发表于：The Lancet Regional Health - Europe · 年份：2025 · DOI：10.1016/j.lanepe.2025.101284 · 被引用次数：11 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cholangiocarcinoma and Gallbladder Cancer Studies、Pancreatic and Hepatic Oncology Research

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....