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

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 s...

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Detalles Bibliográficos
Autores: Korenblik, R, James, S, Smits, J, Díaz-Nieto, R, Davis, R, Chan, BKY, Erdmann, JI, Zijlstra, IAJ, Arntz, PJW, Kollmar, O, Hoffmann, MH, Vass, DG, Lindsay, R, Serenari, M, Cappelli, A, Gobardhan, PD, Imani, F, Suarez, YF, Muños, FG, Grünhagen, DJ, Moelker, A, Pieterman, KJ, Kleeff, J, Wohlgemuth, WA, Herrero, E, Gelabert, A, Breitenstein, S, Seeger, N, Detry, O, Gerard, L, Sandström, PA, Björnsson, B, Aldrighetti, LA, De Cobelli, F, Leclercq, WKG, van Baardewijk, LJ, Croagh, D, De Boo, DW, Kingham, TP, Ridouani, F, Metrakos, P, Valenti, D, Kalil, J, Fretland, ÅA, Carling, U, Martel, G, Ryan, S, Udupa, V, Macdonald, A, Tasse, JC, Stavrou, GA, Spuentrup, E, Borobia, FG, Criado, E, Sparrelid, E, Delle, M, Navinés-López, J, Moragues, JS, Andorrà, EC, Schnitzbauer, A, Vogl, TJ, Heil, J, Primrose, JN, Modi, S, Fouraschen, SMG, Bokkers, RPH, de Boer, MT, Rinkes, IHMB, Smits, MLJ, Gruenberger, T, Baclija, I, Billingsley, KG, Madoff, DC, Serrablo, A, Sarriá, L, Wang, XY, Qu, XD, Winkens, B, Damink, SWLO, Bemelmans, MHA, Dewulf, MJL, Binkert, CA, Schadde, E, van der Leij, C, van Dam, RM
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p6314
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/6314
https://www.scopus.com/inward/record.uri?eid=2-s2.0-105002295349&doi=10.1016%2Fj.lanepe.2025.101284&partnerID=40&md5=9d00db3a307a32888850ef76b81fb3f0
Access Level:acceso abierto
Palabra clave:Portal vein embolization
Hepatic vein embolization
Liver venous deprivation
Colorectal liver metastases
Future liver remnant
Liver resection
FLR hypertrophy
Kinetic growth rate
Post-hepatectomy liver failure
Liver surgery complications
Hepatic regeneration
Multicenter clinical trial
Resection rates
Embolization techniques
Extended liver resection
Regenerative liver procedures
DRAGON 1 trial
Preoperative liver augmentation
Surgical oncology
Bilobar colorectal liver metastases
Descripción
Sumario: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. Copyright (c) 2025 Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

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