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.
Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial / Korenblik, R.; James, S.; Smits, J.; Diaz-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.; Suarez, Y. F.; Munos, F. G.; Grunhagen, D. J.; Moelker, A.; Pieterman, K. J.; Kleeff, J.; Wohlgemuth, W. A.; Herrero, E.; Gelabert, A.; Breitenstein, S.; Seeger, N.; Detry, O.; Gerard, L.; Sandstrom, P. A.; Bjornsson, B.; Aldrighetti, L. A.; De Cobelli, F.; Leclercq, W. K. G.; van Baardewijk, L. J.; Croagh, D.; De Boo, D. W.; Kingham, T. P.; Ridouani, F.; Metrakos, P.; Valenti, D.; Kalil, J.; Fretland, A. A.; Carling, U.; Martel, G.; Ryan, S.; Udupa, V.; Macdonald, A.; Tasse, J. C.; Stavrou, G. A.; Spuentrup, E.; Borobia, F. G.; Criado, E.; Sparrelid, E.; Delle, M.; Navines-Lopez, J.; Moragues, J. S.; Andorra, E. C.; 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.; Sarria, 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.. - In: THE LANCET REGIONAL HEALTH. EUROPE. - ISSN 2666-7762. - 53:(2025). [10.1016/j.lanepe.2025.101284]
Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial
Aldrighetti L. A.;De Cobelli F.;
2025-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
