Article
作者: Grünhagen, Dirk J  ; Imani, Farshad  ; Andorrà, Esteban Cugat  ; Seeger, Nico  ; Moragues, Jaume Sampere  ; Herrero, Eric  ; Dewulf, Maxime J L  ; Serenari, Matteo  ; Billingsley, Kevin G  ; Arntz, Pieter J W  ; van Baardewijk, Laurens J  ; Leclercq, Wouter K G  ; Fretland, Åsmund A  ; Lindsay, Richard  ; Vogl, Thomas J  ; Bemelmans, Marc H A  ; Hoffmann, Martin H  ; Ryan, Stephen  ; Xudong, Qu  ; Navinés-López, Jordi  ; Erdmann, Joris I  ; van Dam, Ronald M  ; Korenblik, Remon  ; Baclija, Ivan  ; Wang, Xiaoying  ; Zijlstra, IJsbrand A J  ; Schnitzbauer, Andreas  ; Wohlgemuth, Walter A  ; Udupa, Venkatesha  ; Delle, Martin  ; Fouraschen, Suomi M G  ; De Cobelli, Francesco  ; Carling, Ulrik  ; Criado, Eva  ; Björnsson, Bergthor  ; Macdonald, Andrew  ; Suarez, Yiliam Fundora  ; Vass, David G  ; Díaz-Nieto, Rafael  ; Detry, Olivier  ; Madoff, David C  ; Pieterman, Kay J  ; Davis, Rob  ; Heil, Jan  ; Binkert, Christoph A  ; Metrakos, Peter  ; Serrablo, Alejandro  ; Primrose, John N  ; Aldrighetti, Luca A  ; Ridouani, Fourat  ; Kleeff, Jörg  ; Borel Rinkes, Inne H M  ; Stavrou, Gregor A  ; Kalil, Jennifer  ; Moelker, Adriaan  ; Smits, Jens  ; de Boer, Marieke T  ; Olde Damink, Steven W L  ; Sparrelid, Ernesto  ; Gelabert, Arantxa  ; Sarriá, Luis  ; Kollmar, Otto  ; Modi, Sachin  ; Chan, Benjamin K Y  ; Bokkers, Reinoud P H  ; Gruenberger, Thomas  ; Schadde, Erik  ; De Boo, Diederick W  ; Muños, Fernando Gómez  ; Valenti, David  ; van der Leij, Christiaan  ; Spuentrup, Elmar  ; Winkens, Bjorn  ; Martel, Guillaume  ; Cappelli, Alberto  ; Sandström, Per A  ; Kingham, T Peter  ; Gerard, Laurent  ; Borobia, Francisco G  ; Gobardhan, Paul D  ; Croagh, Daniel  ; Breitenstein, Stefan  ; Smits, Maarten L J  ; James, Sinéad  ; Tasse, Jordan C 
BackgroundMajor 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.MethodsDRAGON 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.FindingsIn 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%).InterpretationDRAGON 1 demonstrates that PVE/HVE is safe, with no embolization-related mortality, low morbidity, and high resection rates in upfront unresectable CRLM.FundingThe Dutch Cancer Society, National Institute for Health and Care Research UK, Maastricht UMC+, Abbott Laboratories and Guerbet.