TY - JOUR
T1 - Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1)
T2 - a multicentre, single-arm clinical trial
AU - Korenblik, Remon
AU - James, Sinéad
AU - Smits, Jens
AU - Díaz-Nieto, Rafael
AU - Davis, Rob
AU - Chan, Benjamin K.Y.
AU - Erdmann, Joris I.
AU - Zijlstra, IJsbrand A.J.
AU - Arntz, Pieter J.W.
AU - Kollmar, Otto
AU - Hoffmann, Martin H.
AU - Vass, David G.
AU - Lindsay, Richard
AU - Serenari, Matteo
AU - Cappelli, Alberto
AU - Gobardhan, Paul D.
AU - Imani, Farshad
AU - Suarez, Yiliam Fundora
AU - Muños, Fernando Gómez
AU - Grünhagen, Dirk J.
AU - Moelker, Adriaan
AU - Pieterman, Kay J.
AU - Kleeff, Jörg
AU - Wohlgemuth, Walter A.
AU - Herrero, Eric
AU - Gelabert, Arantxa
AU - Breitenstein, Stefan
AU - Seeger, Nico
AU - Detry, Olivier
AU - Gerard, Laurent
AU - Sandström, Per A.
AU - Björnsson, Bergthor
AU - Aldrighetti, Luca A.
AU - De Cobelli, Francesco
AU - Leclercq, Wouter K.G.
AU - van Baardewijk, Laurens J.
AU - Croagh, Daniel
AU - De Boo, Diederick W.
AU - Kingham, T. Peter
AU - Ridouani, Fourat
AU - Metrakos, Peter
AU - Valenti, David
AU - Kalil, Jennifer
AU - Fretland, Åsmund A.
AU - Carling, Ulrik
AU - Martel, Guillaume
AU - Bokkers, Reinoud P.H.
AU - de Boer, Marieke T.
AU - Borel Rinkes, Inne H.M.
AU - Smits, Maarten L.J.
N1 - Publisher Copyright:
© 2025
PY - 2025/6
Y1 - 2025/6
N2 - 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.
AB - 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.
KW - Bilobar colorectal liver metastases
KW - Colorectal liver metastases
KW - DRAGON 1 trial
KW - Embolization techniques
KW - Extended liver resection
KW - FLR hypertrophy
KW - Future liver remnant
KW - Hepatic regeneration
KW - Hepatic vein embolization
KW - Kinetic growth rate
KW - Liver resection
KW - Liver surgery complications
KW - Liver venous deprivation
KW - Multicenter clinical trial
KW - Portal vein embolization
KW - Post-hepatectomy liver failure
KW - Preoperative liver augmentation
KW - Regenerative liver procedures
KW - Resection rates
KW - Surgical oncology
UR - https://www.scopus.com/pages/publications/105002295349
U2 - 10.1016/j.lanepe.2025.101284
DO - 10.1016/j.lanepe.2025.101284
M3 - Article
AN - SCOPUS:105002295349
SN - 2666-7762
VL - 53
JO - The Lancet Regional Health - Europe
JF - The Lancet Regional Health - Europe
M1 - 101284
ER -