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

Remon Korenblik; Sinéad James; Jens Smits; Rafael Díaz-Nieto; Rob Davis; Benjamin K.Y. Chan; Joris I. Erdmann; IJsbrand A.J. Zijlstra; Pieter J.W. Arntz; Otto Kollmar; Martin H. Hoffmann; David G. Vass; Richard Lindsay; Matteo Serenari; Alberto Cappelli; Paul D. Gobardhan; Farshad Imani; Yiliam Fundora Suarez; Fernando Gómez Muños; Dirk J. Grünhagen; Adriaan Moelker; Kay J. Pieterman; Jörg Kleeff; Walter A. Wohlgemuth; Eric Herrero; Arantxa Gelabert; Stefan Breitenstein; Nico Seeger; Olivier Detry; Laurent Gerard; Per A. Sandström; Bergthor Björnsson; Luca A. Aldrighetti; Francesco De Cobelli; Wouter K.G. Leclercq; Laurens J. van Baardewijk; Daniel Croagh; Diederick W. De Boo; T. Peter Kingham; Fourat Ridouani; Peter Metrakos; David Valenti; Jennifer Kalil; Åsmund A. Fretland; Ulrik Carling; Guillaume Martel; Stephen Ryan; Venkatesha Udupa; Andrew Macdonald; Jordan C. Tasse; Gregor A. Stavrou; Elmar Spuentrup; Francisco G. Borobia; Eva Criado; Ernesto Sparrelid; Martin Delle; Jordi Navinés-López; Jaume Sampere Moragues; Esteban Cugat Andorrà; Andreas Schnitzbauer; Thomas J. Vogl; Jan Heil; John N. Primrose; Sachin Modi; Suomi M.G. Fouraschen; Reinoud P.H. Bokkers; Marieke T. de Boer; Inne H.M. Borel Rinkes; Maarten L.J. Smits; Thomas Gruenberger; Ivan Baclija; Kevin G. Billingsley; David C. Madoff; Alejandro Serrablo; Luis Sarriá; Xiaoying Wang; Qu Xudong; Bjorn Winkens; Steven W.L. Olde Damink; Marc H.A. Bemelmans; Maxime J.L. Dewulf; Christoph A. Binkert; Erik Schadde; Christiaan van der Leij; Ronald M. van Dam; for the DRAGON collaborative study group

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

Remon Korenblik
, Sinéad James
, Jens Smits
, Rafael Díaz-Nieto
, Rob Davis
, Benjamin K.Y. Chan
, Joris I. Erdmann
, IJsbrand A.J. Zijlstra
, Pieter J.W. Arntz
, Otto Kollmar
, Martin H. Hoffmann
, David G. Vass
, Richard Lindsay
, Matteo Serenari
, Alberto Cappelli
, Paul D. Gobardhan
, Farshad Imani
, Yiliam Fundora Suarez
, Fernando Gómez Muños
, Dirk J. Grünhagen

Adriaan Moelker, Kay J. Pieterman, Jörg Kleeff, Walter A. Wohlgemuth, Eric Herrero, Arantxa Gelabert, Stefan Breitenstein, Nico Seeger, Olivier Detry, Laurent Gerard, Per A. Sandström, Bergthor Björnsson, Luca A. Aldrighetti, Francesco De Cobelli, Wouter K.G. Leclercq, Laurens J. van Baardewijk, Daniel Croagh, Diederick W. De Boo, T. Peter Kingham, Fourat Ridouani, Peter Metrakos, David Valenti, Jennifer Kalil, Åsmund A. Fretland, Ulrik Carling, Guillaume Martel, Stephen Ryan, Venkatesha Udupa, Andrew Macdonald, Jordan C. Tasse, Gregor A. Stavrou, Elmar Spuentrup, Francisco G. Borobia, Eva Criado, Ernesto Sparrelid, Martin Delle, Jordi Navinés-López, Jaume Sampere Moragues, Esteban Cugat Andorrà, Andreas Schnitzbauer, Thomas J. Vogl, Jan Heil, John N. Primrose, Sachin Modi, Suomi M.G. Fouraschen, Reinoud P.H. Bokkers, Marieke T. de Boer, Inne H.M. Borel Rinkes, Maarten L.J. Smits, Thomas Gruenberger, Ivan Baclija, Kevin G. Billingsley, David C. Madoff, Alejandro Serrablo, Luis Sarriá, Xiaoying Wang, Qu Xudong, Bjorn Winkens, Steven W.L. Olde Damink, Marc H.A. Bemelmans, Maxime J.L. Dewulf, Christoph A. Binkert, Erik Schadde, Christiaan van der Leij, Ronald M. van Dam, for the DRAGON collaborative study group

Research output: Contribution to journal › Article › Research › peer-review

17 Citations (Scopus)

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.

Original language	English
Article number	101284
Number of pages	13
Journal	The Lancet Regional Health - Europe
Volume	53
DOIs	https://doi.org/10.1016/j.lanepe.2025.101284
Publication status	Published - Jun 2025

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Bilobar colorectal liver metastases
Colorectal liver metastases
DRAGON 1 trial
Embolization techniques
Extended liver resection
FLR hypertrophy
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

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10.1016/j.lanepe.2025.101284Licence: CC BY-NC-ND

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Korenblik, R., James, S., Smits, J., Díaz-Nieto, R., Davis, R., Chan, B. K. Y., Erdmann, J. I., Zijlstra, IJ. 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., Muños, F. G., ... for the DRAGON collaborative study group (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{2f9f55ce5b6c4cd29cca6c10c0a7559b,

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 metastases, Colorectal liver metastases, DRAGON 1 trial, Embolization techniques, Extended liver resection, FLR hypertrophy, 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 = "Remon Korenblik and Sin{\'e}ad James and Jens Smits and Rafael D{\'i}az-Nieto and Rob Davis and Chan, \{Benjamin K.Y.\} and Erdmann, \{Joris I.\} and Zijlstra, \{IJsbrand A.J.\} and Arntz, \{Pieter J.W.\} and Otto Kollmar and Hoffmann, \{Martin H.\} and Vass, \{David G.\} and Richard Lindsay and Matteo Serenari and Alberto Cappelli and Gobardhan, \{Paul D.\} and Farshad Imani and Suarez, \{Yiliam Fundora\} and Mu{\~n}os, \{Fernando G{\'o}mez\} and Gr{\"u}nhagen, \{Dirk J.\} and Adriaan Moelker and Pieterman, \{Kay J.\} and J{\"o}rg Kleeff and Wohlgemuth, \{Walter A.\} and Eric Herrero and Arantxa Gelabert and Stefan Breitenstein and Nico Seeger and Olivier Detry and Laurent Gerard and Sandstr{\"o}m, \{Per A.\} and Bergthor Bj{\"o}rnsson and Aldrighetti, \{Luca A.\} and \{De Cobelli\}, Francesco and Leclercq, \{Wouter K.G.\} and \{van Baardewijk\}, \{Laurens J.\} and Daniel Croagh and \{De Boo\}, \{Diederick W.\} and Kingham, \{T. Peter\} and Fourat Ridouani and Peter Metrakos and David Valenti and Jennifer Kalil and Fretland, \{{\AA}smund A.\} and Ulrik Carling and Guillaume Martel and Stephen Ryan and Venkatesha Udupa and Andrew Macdonald and Tasse, \{Jordan C.\} and Stavrou, \{Gregor A.\} and Elmar Spuentrup and Borobia, \{Francisco G.\} and Eva Criado and Ernesto Sparrelid and Martin Delle and Jordi Navin{\'e}s-L{\'o}pez and Moragues, \{Jaume Sampere\} and Andorr{\`a}, \{Esteban Cugat\} and Andreas Schnitzbauer and Vogl, \{Thomas J.\} and Jan Heil and Primrose, \{John N.\} and Sachin Modi and Fouraschen, \{Suomi M.G.\} and Bokkers, \{Reinoud P.H.\} and \{de Boer\}, \{Marieke T.\} and \{Borel Rinkes\}, \{Inne H.M.\} and Smits, \{Maarten L.J.\} and Thomas Gruenberger and Ivan Baclija and Billingsley, \{Kevin G.\} and Madoff, \{David C.\} and Alejandro Serrablo and Luis Sarri{\'a} and Xiaoying Wang and Qu Xudong and Bjorn Winkens and \{Olde Damink\}, \{Steven W.L.\} and Bemelmans, \{Marc H.A.\} and Dewulf, \{Maxime J.L.\} and Binkert, \{Christoph A.\} and Erik Schadde and \{van der Leij\}, Christiaan and \{van Dam\}, \{Ronald M.\} and \{for the DRAGON collaborative study group\}",

note = "Publisher Copyright: {\textcopyright} 2025",

year = "2025",

month = jun,

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

language = "English",

volume = "53",

journal = "The Lancet Regional Health - Europe",

issn = "2666-7762",

publisher = "The Lancet Publishing Group",

}

Korenblik, R, James, S, Smits, J, Díaz-Nieto, R, Davis, R, Chan, BKY, Erdmann, JI, Zijlstra, IJAJ, 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, 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 & for the DRAGON collaborative study group 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

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 - Ryan, Stephen

AU - Udupa, Venkatesha

AU - Macdonald, Andrew

AU - Tasse, Jordan C.

AU - Stavrou, Gregor A.

AU - Spuentrup, Elmar

AU - Borobia, Francisco G.

AU - Criado, Eva

AU - Sparrelid, Ernesto

AU - Delle, Martin

AU - Navinés-López, Jordi

AU - Moragues, Jaume Sampere

AU - Andorrà, Esteban Cugat

AU - Schnitzbauer, Andreas

AU - Vogl, Thomas J.

AU - Heil, Jan

AU - Primrose, John N.

AU - Modi, Sachin

AU - Fouraschen, Suomi M.G.

AU - Bokkers, Reinoud P.H.

AU - de Boer, Marieke T.

AU - Borel Rinkes, Inne H.M.

AU - Smits, Maarten L.J.

AU - Gruenberger, Thomas

AU - Baclija, Ivan

AU - Billingsley, Kevin G.

AU - Madoff, David C.

AU - Serrablo, Alejandro

AU - Sarriá, Luis

AU - Wang, Xiaoying

AU - Xudong, Qu

AU - Winkens, Bjorn

AU - Olde Damink, Steven W.L.

AU - Bemelmans, Marc H.A.

AU - Dewulf, Maxime J.L.

AU - Binkert, Christoph A.

AU - Schadde, Erik

AU - van der Leij, Christiaan

AU - van Dam, Ronald M.

AU - for the DRAGON collaborative study group

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

C2 - 40255933

AN - SCOPUS:105002295349

SN - 2666-7762

VL - 53

JO - The Lancet Regional Health - Europe

JF - The Lancet Regional Health - Europe

M1 - 101284

ER -

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

Abstract

UN SDGs

Keywords

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