Article (Scientific journals)
Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy.
Korenblik, R; Olij, B; Aldrighetti, L A et al.
2022In Cardiovascular and Interventional Radiology, 45 (9), p. 1391-1398
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Keywords :
Colorectal cancer liver metastases (CRLM); Combined portal- and hepatic vein embolization (PVE/HVE); Future liver remnant (FLR); Hepatic vein embolization (HVE); Liver hypertrophy; Portal vein embolization (PVE); DRAGON
Abstract :
[en] STUDY PURPOSE: The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases. METHODS: The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection. RESULTS: Not applicable. CONCLUSION: DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR. TRIAL REGISTRATION: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).
Disciplines :
Radiology, nuclear medicine & imaging
Surgery
Author, co-author :
Korenblik, R ;  GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht Universiteitssingel 40 room 5.452, 6229 ET, Maastricht, The Netherlands. remon.korenblik@mumc.nl ; Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. remon.korenblik@mumc.nl
Olij, B;  GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht Universiteitssingel 40 room 5.452, 6229 ET, Maastricht, The Netherlands ; Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
Aldrighetti, L A;  Department of Surgery, Ospedale San Raffaele, Milan, Italy
Hilal, M Abu;  Department of Surgery, Fondazione Poliambulanza, Brescia, Italy
Ahle, M;  Deparment of Radiology, University Hospital, Linköping, Sweden
Arslan, B;  Department of Radiology, Rush University Medical Center, Chicago, USA
van Baardewijk, L J;  Department of Radiology, Maxima Medisch Centrum, Eindhoven, The Netherlands
Baclija, I;  Department of Radiology, Clinic Favoriten, Vienna, Austria
Bent, C;  Department of Radiology, Bournemouth and Christuchurch, The Royal Bournemouth and Christchurch Hospitals, Bournemouth and Christuchurch, UK
Bertrand, C L;  Department of Surgery, CHU UCLouvain Namur, Namur, Belgium
Björnsson, B;  Department of Surgery, Biomedical and Clinical Sciences, Linköping University Hospital, Linköping, Sweden
de Boer, M T;  Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands
de Boer, S W;  Deparment of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, The Netherlands
Bokkers, R P H;  Department of Radiology, University Medical Center Groningen, Groningen, The Netherlands
Rinkes, I H M Borel;  Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands
Breitenstein, S;  Department of General and Visceral Surgery, Cantonal Hospital Winterthur, Winterthur, Switzerland
Bruijnen, R C G;  Department of Radiology, University Medical Center Utrecht, Utrecht, The Netherlands
Bruners, P;  Department of Radiology, University Hospital Aachen, Aachen, Germany
Büchler, M W;  Department of Surgery, University Hospital Heidelberg, Heidelberg, Germany
Camacho, J C;  Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, USA
Cappelli, A;  Department of Radiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy
Carling, U;  Department of Radiology, University Hospital Oslo, Oslo, Norway
Chan, B K Y;  Department of Surgery, Aintree University Hospitals NHS, Liverpool, UK
Chang, D H;  Department of Radiology, University Hospital Heidelberg, Heidelberg, Germany
Choi, J;  Department of Surgery, Western Health Footscray, Footscray, Australia
Font, J Codina;  Department of Radiology, University Hospital Dr. Josep Trueta de Girona, Girona, Spain
Crawford, M;  Department of Surgery, Royal Prince Alfred Hospital, Camperdown, Australia
Croagh, D;  Department of Surgery, Monash Health, Clayton, Australia
Cugat, E;  Department of Surgery, University Hospital Germans Trias I Pujol, Badalona, Spain
Davis, R;  Department of Radiology, Aintree University Hospitals NHS, Liverpool, UK
De Boo, D W;  Department of Radiology, Monash Health, Clayton, Australia
De Cobelli, F;  Department of Radiology, Ospedale San Raffaele, Milan, Italy
De Wispelaere, J F;  Department of Radiology, CHU UCLouvain Namur, Namur, Belgium
van Delden, O M;  Department of Radiology, Amsterdam University Medical Centers Location AMC, Amsterdam, The Netherlands
Delle, M;  Department of Radiology, Karolinska University Hospital, Stockholm, Sweden
DETRY, Olivier  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de chirurgie abdo, sénologique, endocrine et de transplantation
Díaz-Nieto, R;  Department of Surgery, Aintree University Hospitals NHS, Liverpool, UK
Dili, A;  Department of Surgery, CHU UCLouvain Namur, Namur, Belgium
Erdmann, J I;  Department of Surgery, Amsterdam University Medical Centers Location AMC, Amsterdam, The Netherlands
Fisher, O;  Department of Surgery, Royal Prince Alfred Hospital, Camperdown, Australia
Fondevila, C;  Department of Surgery, Hospital Clínic de Barcelona, Barcelona, Spain
Fretland, Å;  Department of Surgery, University Hospital Oslo, Oslo, Norway
Borobia, F Garcia;  Department of Surgery, Hospital Parc Taulí de Sabadell, Sabadell, Spain
Gelabert, A;  Department of Radiology, Hospital Parc Taulí de Sabadell, Sabadell, Spain ; Department of Radiology, University Hospital Mútua Terassa, Terassa, Spain
GERARD, Laurent ;  Centre Hospitalier Universitaire de Liège - CHU > > Service médical de radiodiagnostic
Giuliante, F;  Department of Surgery, Gemelli University Hospital Rome, Rome, Italy
Gobardhan, P D;  Department of Surgery, Amphia, Breda, The Netherlands
Gómez, F;  Department of Radiology, Hospital Clínic de Barcelona, Barcelona, Spain
Grünberger, T;  Department of Surgery, HPB Center Vienna Health Network, Clinic Favoriten, Vienna, Austria
Grünhagen, D J;  Department of Surgery, Erasmus Medisch Centrum, Rotterdam, The Netherlands
Guitart, J;  Department of Radiology, University Hospital Mútua Terassa, Terassa, Spain
Hagendoorn, J;  Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands
Heil, J;  Department of Surgery, University Hospital Frankfurt, Frankfurt, Germany
Heise, D;  Department of General, Visceral and Transplant Surgery, University Hospital Aachen, Aachen, Germany
Herrero, E;  Department of Surgery, University Hospital Mútua Terassa, Terassa, Spain
Hess, G F;  Department of Surgery, Clarunis University Hospital, Basel, Switzerland
Hoffmann, M H;  Department of Radiology, St. Clara Spital, Basel, Switzerland
Iezzi, R;  Department of Radiology, Gemelli University Hospital, Rome, Italy
Imani, F;  Department of Radiology, Amphia, Breda, The Netherlands
Nguyen, J;  Department of Radiology, Western Health Footscray, Footscray, Australia
Jovine, E;  Department of Surgery, Ospedale Maggiore di Bologna, Bologna, Italy
Kalff, J C;  Department of Surgery, University Hospital Bonn, Bonn, Germany
Kazemier, G;  Department of Surgery, Amsterdam University Medical Centers Location VU, Amsterdam, The Netherlands
Kingham, T P;  Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, USA
Kleeff, J;  Department of Surgery, University Hospital Halle (Saale), Halle, Germany
Kollmar, O;  Department of Surgery, Clarunis University Hospital, Basel, Switzerland
Leclercq, W K G;  Department of Surgery, Maxima Medisch Centrum, Eindhoven, The Netherlands
Ben, S Lopez;  Department of Surgery, University Hospital Dr. Josep Trueta de Girona, Girona, Spain
Lucidi, V;  Department of Surgery, Hôpital Erasme, Brussels, Belgium
MacDonald, A;  Department of Radiology, Oxford University Hospital NHS, Oxford, UK
Madoff, D C;  Department of Radiology, Yale School of Medicine, New Haven, USA
Manekeller, S;  Department of Surgery, University Hospital Bonn, Bonn, Germany
Martel, G;  Department of Surgery, The Ottawa Hospital, Ottawa, Canada
Mehrabi, A;  Department of Surgery, University Hospital Heidelberg, Heidelberg, Germany
Mehrzad, H;  Department of Radiology, Queen Elizabeth Hospital Birmingham NHS, Birmingham, UK
Meijerink, M R;  Department of Radiology, Amsterdam University Medical Centers Location VU, Amsterdam, The Netherlands
Menon, K;  Department of Surgery, King's College Hospital NHS, London, UK
Metrakos, P;  Department of Surgery, McGill University Health Centre, Montréal, Canada
Meyer, C;  Department of Radiology, University Hospital Bonn, Bonn, Germany
Moelker, A;  Department of Radiology and Nuclear Medicine, Erasmus Medisch Centrum, Rotterdam, The Netherlands
Modi, S;  Department of Radiology, University Hospital Southampton NHS, Southampton, UK
Montanari, N;  Department of Radiology, Ospedale Maggiore Di Bologna, Bologna, Italy
Navines, J;  Department of Surgery, University Hospital Germans Trias I Pujol, Badalona, Spain
Neumann, U P;  Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands ; Department of General, Visceral and Transplant Surgery, University Hospital Aachen, Aachen, Germany
Peddu, P;  Department of Radiology, King's College Hospital NHS, London, UK
Primrose, J N;  Department of Surgery, University Hospital Southampton NHS, Southampton, UK
Qu, X;  Department of Radiology, Zhongshan Hospital, Fundan University, Shanghai, China
Raptis, D;  Department of Surgery, Royal Free Hospital NHS, London, UK
Ratti, F;  Department of Surgery, Ospedale San Raffaele, Milan, Italy
Ridouani, F;  Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, USA
Rogan, C;  Department of Radiology, Royal Prince Alfred Hospital, Camperdown, Australia
Ronellenfitsch, U;  Department of Surgery, University Hospital Halle (Saale), Halle, Germany
Ryan, S;  Department of Radiology, The Ottawa Hospital, Ottawa, Canada
Sallemi, C;  Department of Radiology, Fondazione Poliambulanza, Brescia, Italy
Moragues, J Sampere;  Department of Radiology, University Hospital Germans Trias I Pujol, Badalona, Spain
Sandström, P;  Department of Surgery, Biomedical and Clinical Sciences, Linköping University Hospital, Linköping, Sweden
Sarriá, L;  Department of Radiology, University Hospital Miguel Servet, Saragossa, Spain
Schnitzbauer, A;  Department of Surgery, University Hospital Frankfurt, Frankfurt, Germany
Serenari, M;  Department of Surgery, General Surgery and Transplant Unit, IRCCS Azienda Ospedaliero- Universitaria di Bologna, Sant'Orsola-Malpighi Hospital, Bologna, Italy
Serrablo, A;  Department of Surgery, University Hospital Miguel Servet, Saragossa, Spain
Smits, M L J;  Department of Radiology, University Medical Center Utrecht, Utrecht, The Netherlands
Sparrelid, E;  Department of Surgery, Karolinska University Hospital, Stockholm, Sweden
Spüntrup, E;  Department of Radiology, Klinikum Saarbrücken gGmbH, Saarbrücken, Germany
Stavrou, G A;  Department of Surgery, Klinikum Saarbrücken gGmbH, Saarbrücken, Germany
Sutcliffe, R P;  Department of Surgery, Queen Elizabeth Hospital Birmingham NHS, Birmingham, UK
Tancredi, I;  Department of Radiology, Hôpital Erasme, Brussels, Belgium
Tasse, J C;  Department of Radiology, Rush University Medical Center, Chicago, USA
Udupa, V;  Department of Surgery, Oxford University Hospital NHS, Oxford, UK
Valenti, D;  Department of Radiology, McGill University Health Centre, Montréal, Canada
Fundora, Y;  Department of Surgery, Hospital Clínic de Barcelona, Barcelona, Spain
Vogl, T J;  Department of Radiology, University Hosptital Frankfurt, Frankfurt, Germany
Wang, X;  Department of Surgery, Zhongshan Hospital, Fundan University, Shanghai, China
White, S A;  Department of Surgery, Newcastle Upon Tyne Hospitals NHS, Newcastle upon Tyne, UK
Wohlgemuth, W A;  Department of Radiology, University Hospital Halle (Saale), Halle, Germany
Yu, D;  Department of Radiology, Royal Free Hospital NHS, London, UK
Zijlstra, I A J;  Department of Radiology, Amsterdam University Medical Centers Location VU, Amsterdam, The Netherlands
Binkert, C A;  Department of Radiology, Cantonal Hospital Winterthur, Winterthur, Switzerland
Bemelmans, M H A;  Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands ; Department of General, Visceral and Transplant Surgery, University Hospital Aachen, Aachen, Germany
van der Leij, C;  Deparment of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, The Netherlands
Schadde, E;  Department of General and Visceral Surgery, Cantonal Hospital Winterthur, Winterthur, Switzerland ; Department of Surgery, Rush University Medical Center Chicago, Chicago, USA
van Dam, R M;  GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht Universiteitssingel 40 room 5.452, 6229 ET, Maastricht, The Netherlands. r.van.dam@mumc.nl ; Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. r.van.dam@mumc.nl ; Department of General, Visceral and Transplant Surgery, University Hospital Aachen, Aachen, Germany. r.van.dam@mumc.nl
More authors (111 more) Less
Language :
English
Title :
Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy.
Publication date :
05 September 2022
Journal title :
Cardiovascular and Interventional Radiology
ISSN :
0174-1551
eISSN :
1432-086X
Publisher :
Springer, United States - Delaware
Volume :
45
Issue :
9
Pages :
1391-1398
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 12 August 2022

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