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.