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

R. Korenblik; B. Olij; L. A. Aldrighetti; M. Abu Hilal; M. Ahle; B. Arslan; L. J. van Baardewijk; I. Baclija; C. Bent; C. L. Bertrand; B. Björnsson; M. T. de Boer; S. W. de Boer; R. P.H. Bokkers; I. H.M.Borel Rinkes; S. Breitenstein; R. C.G. Bruijnen; P. Bruners; M. W. Büchler; J. C. Camacho; A. Cappelli; U. Carling; B. K.Y. Chan; D. H. Chang; J. choi; J. Codina Font; M. Crawford; D. Croagh; E. Cugat; R. Davis; D. W. De Boo; F. De Cobelli; J. F. De Wispelaere; O. M. van Delden; M. Delle; O. Detry; R. Díaz-Nieto; A. Dili; J. I. Erdmann; O. Fisher; C. Fondevila; Fretland; F. Garcia Borobia; A. Gelabert; L. Gérard; F. Giuliante; P. D. Gobardhan; F. Gómez; T. Grünberger; D. J. Grünhagen; J. Guitart; J. Hagendoorn; J. Heil; D. Heise; E. Herrero; G. F. Hess; M. H. Hoffmann; R. Iezzi; F. Imani; J. Nguyen; E. Jovine; J. C. Kalff; G. Kazemier; T. P. Kingham; J. Kleeff; O. Kollmar; W. K.G. Leclercq; S. Lopez Ben; V. Lucidi; A. MacDonald; D. C. Madoff; S. Manekeller; G. Martel; A. Mehrabi; H. Mehrzad; M. R. Meijerink; K. Menon; P. Metrakos; C. Meyer; A. Moelker; S. Modi; N. Montanari; J. Navines; U. P. Neumann; P. Peddu; J. N. Primrose; X. Qu; D. Raptis; F. Ratti; F. Ridouani; C. Rogan; U. Ronellenfitsch; S. Ryan; C. Sallemi; J. Sampere Moragues; P. Sandström; L. Sarriá; A. Schnitzbauer; M. Serenari; A. Serrablo; M. L.J. Smits; E. Sparrelid; E. Spüntrup; G. A. Stavrou; R. P. Sutcliffe; I. Tancredi; J. C. Tasse; V. Udupa; D. Valenti; Y. Fundora; T. J. Vogl; X. Wang; S. A. White; W. A. Wohlgemuth; D. Yu; I. A.J. Zijlstra; C. A. Binkert; M. H.A. Bemelmans; C. van der Leij; E. Schadde; R. M. van Dam

doi:10.1007/s00270-022-03176-1

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

R. Korenblik^*
, B. Olij
, L. A. Aldrighetti
, M. Abu Hilal
, M. Ahle
, B. Arslan
, L. J. van Baardewijk
, I. Baclija
, C. Bent
, C. L. Bertrand
, B. Björnsson
, M. T. de Boer
, S. W. de Boer
, R. P.H. Bokkers
, I. H.M.Borel Rinkes
, S. Breitenstein
, R. C.G. Bruijnen
, P. Bruners
, M. W. Büchler
, J. C. Camacho

A. Cappelli, U. Carling, B. K.Y. Chan, D. H. Chang, J. choi, J. Codina Font, M. Crawford, D. Croagh, E. Cugat, R. Davis, D. W. De Boo, F. De Cobelli, J. F. De Wispelaere, O. M. van Delden, M. Delle, O. Detry, R. Díaz-Nieto, A. Dili, J. I. Erdmann, O. Fisher, C. Fondevila, Fretland, F. Garcia Borobia, A. Gelabert, L. Gérard, F. Giuliante, P. D. Gobardhan, F. Gómez, T. Grünberger, D. J. Grünhagen, J. Guitart, J. Hagendoorn, J. Heil, D. Heise, E. Herrero, G. F. Hess, M. H. Hoffmann, R. Iezzi, F. Imani, J. Nguyen, E. Jovine, J. C. Kalff, G. Kazemier, T. P. Kingham, J. Kleeff, O. Kollmar, W. K.G. Leclercq, S. Lopez Ben, V. Lucidi, A. MacDonald, D. C. Madoff, S. Manekeller, G. Martel, A. Mehrabi, H. Mehrzad, M. R. Meijerink, K. Menon, P. Metrakos, C. Meyer, A. Moelker, S. Modi, N. Montanari, J. Navines, U. P. Neumann, P. Peddu, J. N. Primrose, X. Qu, D. Raptis, F. Ratti, F. Ridouani, C. Rogan, U. Ronellenfitsch, S. Ryan, C. Sallemi, J. Sampere Moragues, P. Sandström, L. Sarriá, A. Schnitzbauer, M. Serenari, A. Serrablo, M. L.J. Smits, E. Sparrelid, E. Spüntrup, G. A. Stavrou, R. P. Sutcliffe, I. Tancredi, J. C. Tasse, V. Udupa, D. Valenti, Y. Fundora, T. J. Vogl, X. Wang, S. A. White, W. A. Wohlgemuth, D. Yu, I. A.J. Zijlstra, C. A. Binkert, M. H.A. Bemelmans, C. van der Leij, E. Schadde, R. M. van Dam^*

^*Corresponding author for this work

Maastricht University Medical Centre
Vita-Salute San Raffaele University
Istituto Ospedaliero Fondazione Poliambulanza
Linköping University
Maxima Medical Centre
Department of Radiology
University Hospitals Dorset NHS Foundation Trust
Université catholique de Louvain
University Medical Centre Utrecht
Cantonal Hospital Winterthur
Universitätsklinikum Aachen
University Hospital Heidelberg
Memorial Sloan-Kettering Cancer Center
S. Orsola-Malpighi Hospital
Oslo University Hospital
University Hospital Aintree
University of Girona
Royal Prince Alfred Hospital
Monash Health
Josep Carreras Leukaemia Research Institute
Amsterdam UMC
Karolinska University Hospital
CHU and University of Liège
Hospital Clinic de Barcelona
The Norwegian Radium Hospital
Hospital Parc Taulí de Sabadell
University of Barcelona
Agostino Gemelli University Hospital Foundation IRCCS
Department of Cardiothoracic Surgery
HPB Center Vienna Health Network
University Hospital Frankfurt am Main
Universitätsspital Basel
Ospedale Maggiore
University Hospital Bonn
Universitätsklinik und Poliklinik für Pädiatrie I (Halle)
Hôpital Erasme
Oxford University Hospitals NHS Foundation Trust
Yale University
University of Ottawa
Queen Elizabeth University Hospital (Birmingham)
King’s College Hospital
McGill University Health Centre
University Hospital Southampton NHS Foundation Trust
Fudan University
Royal Free London NHS Foundation Trust
University of Zaragoza
Klinikum Saarbrücken GmbH
Rush University Medical Center (Chicago)
Newcastle upon Tyne Hospitals NHS Foundation Trust
Maastricht University
University Medical Centre Groningen
Western Health Footscray
Aintree University Hospitals NHS Foundation Trust
St. Clara Spital
Amphia Hospital
Fundan University
Zhongshan Hospital
University Hospital RWTH Aachen

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

29 Citations (Scopus)

45 Downloads (Pure)

Abstract

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).

Original language	English
Pages (from-to)	1391-1398
Number of pages	8
Journal	CardioVascular and Interventional Radiology
Volume	45
Issue number	9
Early online date	5 Jul 2022
DOIs	https://doi.org/10.1007/s00270-022-03176-1
Publication status	Published - Sept 2022

Bibliographical note

Funding Information:
The Dutch Cancer Society (KWF), Maastricht University Medical Center, NIHR, Guerbet, and Abbott Laboratories provided unrestricted financial support for monitoring, coordination and the infrastructure of this trial. All funders do not interfere with the initiation, coordination, analyzation, or publication of the results. Maastricht University is the sponsor of the DRAGON 1 trial.

Publisher Copyright:
© 2022, The Author(s).

UN SDGs

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

SDG 3 Good Health and Well-being

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10.1007/s00270-022-03176-1Licence: CC BY

Dragon 1 Protocol Manuscript Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE HVE) to Accelerate Future Liver Remnant (FLR) HypertrophyFinal published version, 322 KBLicence: CC BY

Cite this

Korenblik, R., Olij, B., Aldrighetti, L. A., Hilal, M. A., Ahle, M., Arslan, B., van Baardewijk, L. J., Baclija, I., Bent, C., Bertrand, C. L., Björnsson, B., de Boer, M. T., de Boer, S. W., Bokkers, R. P. H., Rinkes, I. H. M. B., Breitenstein, S., Bruijnen, R. C. G., Bruners, P., Büchler, M. W., ... van Dam, R. M. (2022). 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. CardioVascular and Interventional Radiology, 45(9), 1391-1398. https://doi.org/10.1007/s00270-022-03176-1

@article{6634a1c1f6a14532958dd1db71d24b51,

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",

abstract = "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).",

author = "R. Korenblik and B. Olij and Aldrighetti, \{L. A.\} and Hilal, \{M. Abu\} and M. Ahle and B. Arslan and \{van Baardewijk\}, \{L. J.\} and I. Baclija and C. Bent and Bertrand, \{C. L.\} and B. Bj{\"o}rnsson and \{de Boer\}, \{M. T.\} and \{de Boer\}, \{S. W.\} and Bokkers, \{R. P.H.\} and Rinkes, \{I. H.M.Borel\} and S. Breitenstein and Bruijnen, \{R. C.G.\} and P. Bruners and B{\"u}chler, \{M. W.\} and Camacho, \{J. C.\} and A. Cappelli and U. Carling and Chan, \{B. K.Y.\} and Chang, \{D. H.\} and J. choi and Font, \{J. Codina\} and M. Crawford and D. Croagh and E. Cugat and R. Davis and \{De Boo\}, \{D. W.\} and \{De Cobelli\}, F. and \{De Wispelaere\}, \{J. F.\} and \{van Delden\}, \{O. M.\} and M. Delle and O. Detry and R. D{\'i}az-Nieto and A. Dili and Erdmann, \{J. I.\} and O. Fisher and C. Fondevila and Fretland and Borobia, \{F. Garcia\} and A. Gelabert and L. G{\'e}rard and F. Giuliante and Gobardhan, \{P. D.\} and F. G{\'o}mez and T. Gr{\"u}nberger and Gr{\"u}nhagen, \{D. J.\} and J. Guitart and J. Hagendoorn and J. Heil and D. Heise and E. Herrero and Hess, \{G. F.\} and Hoffmann, \{M. H.\} and R. Iezzi and F. Imani and J. Nguyen and E. Jovine and Kalff, \{J. C.\} and G. Kazemier and Kingham, \{T. P.\} and J. Kleeff and O. Kollmar and Leclercq, \{W. K.G.\} and Ben, \{S. Lopez\} and V. Lucidi and A. MacDonald and Madoff, \{D. C.\} and S. Manekeller and G. Martel and A. Mehrabi and H. Mehrzad and Meijerink, \{M. R.\} and K. Menon and P. Metrakos and C. Meyer and A. Moelker and S. Modi and N. Montanari and J. Navines and Neumann, \{U. P.\} and P. Peddu and Primrose, \{J. N.\} and X. Qu and D. Raptis and F. Ratti and F. Ridouani and C. Rogan and U. Ronellenfitsch and S. Ryan and C. Sallemi and Moragues, \{J. Sampere\} and P. Sandstr{\"o}m and L. Sarri{\'a} and A. Schnitzbauer and M. Serenari and A. Serrablo and Smits, \{M. L.J.\} and E. Sparrelid and E. Sp{\"u}ntrup and Stavrou, \{G. A.\} and Sutcliffe, \{R. P.\} and I. Tancredi and Tasse, \{J. C.\} and V. Udupa and D. Valenti and Y. Fundora and Vogl, \{T. J.\} and X. Wang and White, \{S. A.\} and Wohlgemuth, \{W. A.\} and D. Yu and Zijlstra, \{I. A.J.\} and Binkert, \{C. A.\} and Bemelmans, \{M. H.A.\} and \{van der Leij\}, C. and E. Schadde and \{van Dam\}, \{R. M.\}",

note = "Funding Information: The Dutch Cancer Society (KWF), Maastricht University Medical Center, NIHR, Guerbet, and Abbott Laboratories provided unrestricted financial support for monitoring, coordination and the infrastructure of this trial. All funders do not interfere with the initiation, coordination, analyzation, or publication of the results. Maastricht University is the sponsor of the DRAGON 1 trial. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = sep,

doi = "10.1007/s00270-022-03176-1",

language = "English",

volume = "45",

pages = "1391--1398",

journal = "CardioVascular and Interventional Radiology",

issn = "0174-1551",

publisher = "Springer",

number = "9",

}

Korenblik, R, Olij, B, Aldrighetti, LA, Hilal, MA, Ahle, M, Arslan, B, van Baardewijk, LJ, Baclija, I, Bent, C, Bertrand, CL, Björnsson, B, de Boer, MT, de Boer, SW, Bokkers, RPH, Rinkes, IHMB, Breitenstein, S, Bruijnen, RCG, Bruners, P, Büchler, MW, Camacho, JC, Cappelli, A, Carling, U, Chan, BKY, Chang, DH, choi, J, Font, JC, Crawford, M, Croagh, D, Cugat, E, Davis, R, De Boo, DW, De Cobelli, F, De Wispelaere, JF, van Delden, OM, Delle, M, Detry, O, Díaz-Nieto, R, Dili, A, Erdmann, JI, Fisher, O, Fondevila, C, Fretland, Borobia, FG, Gelabert, A, Gérard, L, Giuliante, F, Gobardhan, PD, Gómez, F, Grünberger, T, Grünhagen, DJ, Guitart, J, Hagendoorn, J, Heil, J, Heise, D, Herrero, E, Hess, GF, Hoffmann, MH, Iezzi, R, Imani, F, Nguyen, J, Jovine, E, Kalff, JC, Kazemier, G, Kingham, TP, Kleeff, J, Kollmar, O, Leclercq, WKG, Ben, SL, Lucidi, V, MacDonald, A, Madoff, DC, Manekeller, S, Martel, G, Mehrabi, A, Mehrzad, H, Meijerink, MR, Menon, K, Metrakos, P, Meyer, C, Moelker, A, Modi, S, Montanari, N, Navines, J, Neumann, UP, Peddu, P, Primrose, JN, Qu, X, Raptis, D, Ratti, F, Ridouani, F, Rogan, C, Ronellenfitsch, U, Ryan, S, Sallemi, C, Moragues, JS, Sandström, P, Sarriá, L, Schnitzbauer, A, Serenari, M, Serrablo, A, Smits, MLJ, Sparrelid, E, Spüntrup, E, Stavrou, GA, Sutcliffe, RP, Tancredi, I, Tasse, JC, Udupa, V, Valenti, D, Fundora, Y, Vogl, TJ, Wang, X, White, SA, Wohlgemuth, WA, Yu, D, Zijlstra, IAJ, Binkert, CA, Bemelmans, MHA, van der Leij, C, Schadde, E & van Dam, RM 2022, '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', CardioVascular and Interventional Radiology, vol. 45, no. 9, pp. 1391-1398. https://doi.org/10.1007/s00270-022-03176-1

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.
In: CardioVascular and Interventional Radiology, Vol. 45, No. 9, 09.2022, p. 1391-1398.

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

TY - JOUR

T1 - Dragon 1 Protocol Manuscript

T2 - Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy

AU - Korenblik, R.

AU - Olij, B.

AU - Aldrighetti, L. A.

AU - Hilal, M. Abu

AU - Ahle, M.

AU - Arslan, B.

AU - van Baardewijk, L. J.

AU - Baclija, I.

AU - Bent, C.

AU - Bertrand, C. L.

AU - Björnsson, B.

AU - de Boer, M. T.

AU - de Boer, S. W.

AU - Bokkers, R. P.H.

AU - Rinkes, I. H.M.Borel

AU - Breitenstein, S.

AU - Bruijnen, R. C.G.

AU - Bruners, P.

AU - Büchler, M. W.

AU - Camacho, J. C.

AU - Cappelli, A.

AU - Carling, U.

AU - Chan, B. K.Y.

AU - Chang, D. H.

AU - choi, J.

AU - Font, J. Codina

AU - Crawford, M.

AU - Croagh, D.

AU - Cugat, E.

AU - Davis, R.

AU - De Boo, D. W.

AU - De Cobelli, F.

AU - De Wispelaere, J. F.

AU - van Delden, O. M.

AU - Delle, M.

AU - Detry, O.

AU - Díaz-Nieto, R.

AU - Dili, A.

AU - Erdmann, J. I.

AU - Fisher, O.

AU - Fondevila, C.

AU - Fretland,

AU - Borobia, F. Garcia

AU - Gelabert, A.

AU - Gérard, L.

AU - Giuliante, F.

AU - Gobardhan, P. D.

AU - Gómez, F.

AU - Grünberger, T.

AU - Grünhagen, D. J.

AU - Guitart, J.

AU - Hagendoorn, J.

AU - Heil, J.

AU - Heise, D.

AU - Herrero, E.

AU - Hess, G. F.

AU - Hoffmann, M. H.

AU - Iezzi, R.

AU - Imani, F.

AU - Nguyen, J.

AU - Jovine, E.

AU - Kalff, J. C.

AU - Kazemier, G.

AU - Kingham, T. P.

AU - Kleeff, J.

AU - Kollmar, O.

AU - Leclercq, W. K.G.

AU - Ben, S. Lopez

AU - Lucidi, V.

AU - MacDonald, A.

AU - Madoff, D. C.

AU - Manekeller, S.

AU - Martel, G.

AU - Mehrabi, A.

AU - Mehrzad, H.

AU - Meijerink, M. R.

AU - Menon, K.

AU - Metrakos, P.

AU - Meyer, C.

AU - Moelker, A.

AU - Modi, S.

AU - Montanari, N.

AU - Navines, J.

AU - Neumann, U. P.

AU - Peddu, P.

AU - Primrose, J. N.

AU - Qu, X.

AU - Raptis, D.

AU - Ratti, F.

AU - Ridouani, F.

AU - Rogan, C.

AU - Ronellenfitsch, U.

AU - Ryan, S.

AU - Sallemi, C.

AU - Moragues, J. Sampere

AU - Sandström, P.

AU - Sarriá, L.

AU - Schnitzbauer, A.

AU - Serenari, M.

AU - Serrablo, A.

AU - Smits, M. L.J.

AU - Sparrelid, E.

AU - Spüntrup, E.

AU - Stavrou, G. A.

AU - Sutcliffe, R. P.

AU - Tancredi, I.

AU - Tasse, J. C.

AU - Udupa, V.

AU - Valenti, D.

AU - Fundora, Y.

AU - Vogl, T. J.

AU - Wang, X.

AU - White, S. A.

AU - Wohlgemuth, W. A.

AU - Yu, D.

AU - Zijlstra, I. A.J.

AU - Binkert, C. A.

AU - Bemelmans, M. H.A.

AU - van der Leij, C.

AU - Schadde, E.

AU - van Dam, R. M.

N1 - Funding Information: The Dutch Cancer Society (KWF), Maastricht University Medical Center, NIHR, Guerbet, and Abbott Laboratories provided unrestricted financial support for monitoring, coordination and the infrastructure of this trial. All funders do not interfere with the initiation, coordination, analyzation, or publication of the results. Maastricht University is the sponsor of the DRAGON 1 trial. Publisher Copyright: © 2022, The Author(s).

PY - 2022/9

Y1 - 2022/9

N2 - 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).

AB - 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).

UR - https://www.scopus.com/pages/publications/85133472396

U2 - 10.1007/s00270-022-03176-1

DO - 10.1007/s00270-022-03176-1

M3 - Article

C2 - 35790566

AN - SCOPUS:85133472396

SN - 0174-1551

VL - 45

SP - 1391

EP - 1398

JO - CardioVascular and Interventional Radiology

JF - CardioVascular and Interventional Radiology

IS - 9

ER -

Korenblik R, Olij B, Aldrighetti LA, Hilal MA, Ahle M, Arslan B et al. 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. CardioVascular and Interventional Radiology. 2022 Sept;45(9):1391-1398. Epub 2022 Jul 5. doi: 10.1007/s00270-022-03176-1

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

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