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

R. Korenblik; S. James; J. Smits; R. Díaz-Nieto; R. Davis; B.K.Y. Chan; J.I. Erdmann; I.A.J. Zijlstra; P.J.W. Arntz; O. Kollmar; M.H. Hoffmann; D.G. Vass; R. Lindsay; M. Serenari; A. Cappelli; P.D. Gobardhan; F. Imani; Yiliam Fundora Suarez; Fernando Gómez Muños; D.J. Grünhagen; A. Moelker; K.J. Pieterman; J. Kleeff; W.A. Wohlgemuth; E. Herrero; A. Gelabert; S. Breitenstein; N. Seeger; O. Detry; L. Gerard; P.A. Sandström; B. Björnsson; L.A. Aldrighetti; F. De Cobelli; W.K.G. Leclercq; L.J. van Baardewijk; D. Croagh; D.W. De Boo; T.P. Kingham; F. Ridouani; P. Metrakos; D. Valenti; J. Kalil; Å.A. Fretland; U. Carling; G. Martel; S. Ryan; V. Udupa; A. Macdonald; J.C. Tasse; G.A. Stavrou; E. Spuentrup; Francisco G. Borobia; Eva Criado; E. Sparrelid; M. Delle; Jordi Navinés-López; Jaume Sampere Moragues; Esteban Cugat Andorrà; A. Schnitzbauer; T.J. Vogl; J. Heil; J.N. Primrose; S. Modi; S.M.G. Fouraschen; R.P.H. Bokkers; M.T. de Boer; I.H.M. Borel Rinkes; M.L.J. Smits; T. Gruenberger; I. Baclija; K.G. Billingsley; D.C. Madoff; A. Serrablo; L. Sarriá; X. Wang; Q. Xudong; B. Winkens; S.W.L. Olde Damink; M.H.A. Bemelmans; M.J.L. Dewulf; C.A. Binkert; E. Schadde; C. van der Leij; R.M. van Dam

doi: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

R. Korenblik, S. James, J. Smits, R. Díaz-Nieto, R. Davis, B.K.Y. Chan, J.I. Erdmann, I.A.J. Zijlstra, P.J.W. Arntz, O. Kollmar, M.H. Hoffmann, D.G. Vass, R. Lindsay, M. Serenari, A. Cappelli, P.D. Gobardhan, F. Imani, Yiliam Fundora Suarez, Fernando Gómez Muños, D.J. GrünhagenA. Moelker, K.J. Pieterman, J. Kleeff, W.A. Wohlgemuth, E. Herrero, A. Gelabert, S. Breitenstein, N. Seeger, O. Detry, L. Gerard, P.A. Sandström, B. Björnsson, L.A. Aldrighetti, F. De Cobelli, W.K.G. Leclercq, L.J. van Baardewijk, D. Croagh, D.W. De Boo, T.P. Kingham, F. Ridouani, P. Metrakos, D. Valenti, J. Kalil, Å.A. Fretland, U. Carling, G. Martel, S. Ryan, V. Udupa, A. Macdonald, J.C. Tasse, G.A. Stavrou, E. Spuentrup, Francisco G. Borobia, Eva Criado, E. Sparrelid, M. Delle, Jordi Navinés-López, Jaume Sampere Moragues, Esteban Cugat Andorrà, A. Schnitzbauer, T.J. Vogl, J. Heil, J.N. Primrose, S. Modi, S.M.G. Fouraschen, R.P.H. Bokkers, M.T. de Boer, I.H.M. Borel Rinkes, M.L.J. Smits, T. Gruenberger, I. Baclija, K.G. Billingsley, D.C. Madoff, A. Serrablo, L. Sarriá, X. Wang, Q. Xudong, B. Winkens, S.W.L. Olde Damink, M.H.A. Bemelmans, M.J.L. Dewulf, C.A. Binkert, E. Schadde, C. van der Leij, R.M. van Dam

Departament de Cirurgia

Producció científica: Contribució a revista › Article › Recerca › Avaluat per experts

7 Cites (Scopus)

Resum

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.

Idioma original	Anglès
Número d’article	101284
Nombre de pàgines	13
Revista	The Lancet Regional Health - Europe
Volum	53
DOIs	https://doi.org/10.1016/j.lanepe.2025.101284
Estat de la publicació	Publicada - de juny 2025

SDG de les Nacions Unides

Aquest resultat contribueix als següents objectius de desenvolupament sostenible.

Accés al document

10.1016/j.lanepe.2025.101284

https://ddd.uab.cat/record/319532

Altres arxius i enllaços

Com citar-ho

Korenblik, R., 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, Y., Gómez Muños, F., ... van Dam, R. M. (2025). Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1) : a multicentre, single-arm clinical trial. The Lancet Regional Health - Europe, 53, Article 101284. https://doi.org/10.1016/j.lanepe.2025.101284

@article{fb7340b3f86544398b9ff21c11814cf6,

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

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.",

keywords = "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",

author = "R. Korenblik and S. James and J. Smits and R. D{\'i}az-Nieto and R. Davis and B.K.Y. Chan and J.I. Erdmann and I.A.J. Zijlstra and P.J.W. Arntz and O. Kollmar and M.H. Hoffmann and D.G. Vass and R. Lindsay and M. Serenari and A. Cappelli and P.D. Gobardhan and F. Imani and \{Fundora Suarez\}, Yiliam and \{G{\'o}mez Mu{\~n}os\}, Fernando and D.J. Gr{\"u}nhagen and A. Moelker and K.J. Pieterman and J. Kleeff and W.A. Wohlgemuth and E. Herrero and A. Gelabert and S. Breitenstein and N. Seeger and O. Detry and L. Gerard and P.A. Sandstr{\"o}m and B. Bj{\"o}rnsson and L.A. Aldrighetti and \{De Cobelli\}, F. and W.K.G. Leclercq and \{van Baardewijk\}, L.J. and D. Croagh and \{De Boo\}, D.W. and T.P. Kingham and F. Ridouani and P. Metrakos and D. Valenti and J. Kalil and {\AA}.A. Fretland and U. Carling and G. Martel and S. Ryan and V. Udupa and A. Macdonald and J.C. Tasse and G.A. Stavrou and E. Spuentrup and Borobia, \{Francisco G.\} and Eva Criado and E. Sparrelid and M. Delle and Jordi Navin{\'e}s-L{\'o}pez and \{Sampere Moragues\}, Jaume and \{Cugat Andorr{\`a}\}, Esteban and A. Schnitzbauer and T.J. Vogl and J. Heil and J.N. Primrose and S. Modi and S.M.G. Fouraschen and R.P.H. Bokkers and \{de Boer\}, M.T. and \{Borel Rinkes\}, I.H.M. and M.L.J. Smits and T. Gruenberger and I. Baclija and K.G. Billingsley and D.C. Madoff and A. Serrablo and L. Sarri{\'a} and X. Wang and Q. Xudong and B. Winkens and \{Olde Damink\}, S.W.L. and M.H.A. Bemelmans and M.J.L. Dewulf and C.A. Binkert and E. Schadde and \{van der Leij\}, C. and \{van Dam\}, R.M.",

year = "2025",

month = jun,

doi = "10.1016/j.lanepe.2025.101284",

language = "English",

volume = "53",

}

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, Fundora Suarez, Y, Gómez Muños, F, 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, Sampere Moragues, J, Cugat Andorrà, E, Schnitzbauer, A, Vogl, TJ, Heil, J, Primrose, JN, Modi, S, Fouraschen, SMG, Bokkers, RPH, de Boer, MT, Borel Rinkes, IHM, Smits, MLJ, Gruenberger, T, Baclija, I, Billingsley, KG, Madoff, DC, Serrablo, A, Sarriá, L, Wang, X, Xudong, Q, Winkens, B, Olde Damink, SWL, Bemelmans, MHA, Dewulf, MJL, Binkert, CA, Schadde, E, van der Leij, C & van Dam, RM 2025, 'Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1) : a multicentre, single-arm clinical trial', The Lancet Regional Health - Europe, vol. 53, 101284. https://doi.org/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. / Korenblik, R.; James, S.; Smits, J. et al.
In: The Lancet Regional Health - Europe, Vol. 53, 101284, 06.2025.

Producció científica: Contribució a revista › Article › Recerca › Avaluat per experts

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, R.

AU - James, S.

AU - Smits, J.

AU - Díaz-Nieto, R.

AU - Davis, R.

AU - Chan, B.K.Y.

AU - Erdmann, J.I.

AU - Zijlstra, I.A.J.

AU - Arntz, P.J.W.

AU - Kollmar, O.

AU - Hoffmann, M.H.

AU - Vass, D.G.

AU - Lindsay, R.

AU - Serenari, M.

AU - Cappelli, A.

AU - Gobardhan, P.D.

AU - Imani, F.

AU - Fundora Suarez, Yiliam

AU - Gómez Muños, Fernando

AU - Grünhagen, D.J.

AU - Moelker, A.

AU - Pieterman, K.J.

AU - Kleeff, J.

AU - Wohlgemuth, W.A.

AU - Herrero, E.

AU - Gelabert, A.

AU - Breitenstein, S.

AU - Seeger, N.

AU - Detry, O.

AU - Gerard, L.

AU - Sandström, P.A.

AU - Björnsson, B.

AU - Aldrighetti, L.A.

AU - De Cobelli, F.

AU - Leclercq, W.K.G.

AU - van Baardewijk, L.J.

AU - Croagh, D.

AU - De Boo, D.W.

AU - Kingham, T.P.

AU - Ridouani, F.

AU - Metrakos, P.

AU - Valenti, D.

AU - Kalil, J.

AU - Fretland, Å.A.

AU - Carling, U.

AU - Martel, G.

AU - Ryan, S.

AU - Udupa, V.

AU - Macdonald, A.

AU - Tasse, J.C.

AU - Stavrou, G.A.

AU - Spuentrup, E.

AU - Borobia, Francisco G.

AU - Criado, Eva

AU - Sparrelid, E.

AU - Delle, M.

AU - Navinés-López, Jordi

AU - Sampere Moragues, Jaume

AU - Cugat Andorrà, Esteban

AU - Schnitzbauer, A.

AU - Vogl, T.J.

AU - Heil, J.

AU - Primrose, J.N.

AU - Modi, S.

AU - Fouraschen, S.M.G.

AU - Bokkers, R.P.H.

AU - de Boer, M.T.

AU - Borel Rinkes, I.H.M.

AU - Smits, M.L.J.

AU - Gruenberger, T.

AU - Baclija, I.

AU - Billingsley, K.G.

AU - Madoff, D.C.

AU - Serrablo, A.

AU - Sarriá, L.

AU - Wang, X.

AU - Xudong, Q.

AU - Winkens, B.

AU - Olde Damink, S.W.L.

AU - Bemelmans, M.H.A.

AU - Dewulf, M.J.L.

AU - Binkert, C.A.

AU - Schadde, E.

AU - van der Leij, C.

AU - van Dam, R.M.

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 mestastases

KW - Colorectal liver metastases

KW - DRAGON 1 trial

KW - Embolization techniques

KW - Extended liver resection

KW - FLR hyperthophy

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

UR - https://www.mendeley.com/catalogue/dacc0595-8c30-3065-9a72-6f6dfe4823fb/

U2 - 10.1016/j.lanepe.2025.101284

DO - 10.1016/j.lanepe.2025.101284

M3 - Article

C2 - 40255933

SN - 2666-7762

VL - 53

JO - The Lancet Regional Health - Europe

JF - The Lancet Regional Health - Europe

M1 - 101284