Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1)

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...

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Authors: Korenblik, R.|||0000-0002-6356-3076, James, S., Smits, J., Díaz-Nieto, R., Davis, R., Chan, B.K.Y., Erdmann, J.I., Zijlstra, I.A.J., Arntz, P.J.W., Kollmar, O., Hoffmann, M.H., Vass, D.G., Lindsay, R., Serenari, M., Cappelli, A., Gobardhan, P.D., Imani, F., Fundora Suarez, Yiliam|||0000-0003-4950-6988, Gómez Muños, Fernando, Grünhagen, D.J., Moelker, A., Pieterman, K.J., Kleeff, J., Wohlgemuth, W.A., Herrero, E., Gelabert, A.|||0000-0003-1817-3500, Breitenstein, S., Seeger, N.|||0000-0002-4943-3304, Detry, O., Gerard, L., Sandström, P.A., Björnsson, Bergthor|||0000-0001-9704-1260, Aldrighetti, L.A., De Cobelli, F., Leclercq, W.K.G.|||0000-0003-1159-1857, van Baardewijk, L.J., Croagh, D.|||0000-0002-6430-6741, De Boo, D.W., Kingham, T.P., Ridouani, F., Metrakos, P., Valenti, D., Kalil, J.|||0000-0001-6304-4690, Fretland, Å.A., Carling, U., Martel, G., Ryan, S., Udupa, V., Macdonald, A., Tasse, J.C., Stavrou, G.A.|||0000-0002-6890-4271, Spuentrup, E., Borobia, Francisco G.|||0000-0002-5147-5124, Criado, Eva, Sparrelid, E., Delle, M., Navinés i López, Jordi|||0000-0003-0805-3863, Sampere Moragues, Jaume|||0000-0001-9438-1358, Cugat Andorrà, Esteban|||0000-0002-9572-6036, Schnitzbauer, A., Vogl, T.J., Heil, J., Primrose, J.N., Modi, S., Fouraschen, S.M.G., Bokkers, R.P.H., de Boer, M.T., Borel Rinkes, I.H.M., Smits, M.L.J., Gruenberger, T., Baclija, I., Billingsley, K.G., Madoff, D.C., Serrablo, A., Sarriá, L., Wang, X., Xudong, Q., Winkens, B., Olde Damink, S.W.L., Bemelmans, M.H.A., Dewulf, M.J.L., Binkert, C.A., Schadde, E., van der Leij, C., van Dam, R.M.
Format: article
Publication Date:2025
Country:España
Institution:Universitat Autònoma de Barcelona
Repository:Dipòsit Digital de Documents de la UAB
Language:English
OAI Identifier:oai:ddd.uab.cat:319532
Online Access:https://ddd.uab.cat/record/319532
https://dx.doi.org/urn:doi:10.1016/j.lanepe.2025.101284
Access Level:Open access
Keyword:Bilobar colorectal liver mestastases
Colorectal liver metastases
DRAGON 1 trial
Embolization techniques
Extended liver resection
FLR hyperthophy
Future liver remnant
Hepatic regeneration
Hepatic vein embolization
Kinetic growth rate
Liver resection
Liver surgery complications
Liver venous deprivation
Multicenter clinical trial
Portal vein embolization
Post-hepatectomy liver failure
Preoperative liver augmentation
Regenerative liver procedures
Resection rates
Surgical oncology
Description
Summary: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.

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