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

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).

10.1007/s00270-022-03176-1

0174-1551

1391–1398

Korenblik, R

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Olij, B

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Aldrighetti, L A

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Hilal, M Abu

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Ahle, M

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Arslan, B

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van Baardewijk, L J

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Baclija, I

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Bent, C

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Bertrand, C L

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Björnsson, B

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de Boer, M T

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de Boer, S W

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Bokkers, R P H

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Rinkes, I H M Borel

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Breitenstein, S

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Bruijnen, R C G

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Bruners, P

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Büchler, M W

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Camacho, J C

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Cappelli, A

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Carling, U

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Chan, B K Y

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Chang, D H

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Choi, J

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Font, J Codina

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Crawford, M

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Croagh, D

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Cugat, E

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Davis, R

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De Boo, D W

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De Cobelli, F

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De Wispelaere, J F

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van Delden, O M

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Delle, M

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Detry, O

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Díaz-Nieto, R

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Dili, A

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Erdmann, J I

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Fisher, O

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Fondevila, C

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Fretland, Å

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Borobia, F Garcia

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Gelabert, A

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Gérard, L

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Giuliante, F

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Gobardhan, P D

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Gómez, F

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Grünberger, T

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Grünhagen, D J

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Guitart, J

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Hagendoorn, J

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Heil, J

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Heise, D

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Herrero, E

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Hess, G F

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Hoffmann, M H

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Iezzi, R

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Imani, F

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Nguyen, J

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Jovine, E

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Kalff, J C

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Kingham, T P

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Leclercq, W K G

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Ben, S Lopez

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Lucidi, V

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MacDonald, A

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Madoff, D C

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Mehrabi, A

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Mehrzad, H

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Meijerink, M R

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Menon, K

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Metrakos, P

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Meyer, C

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Moelker, A

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Modi, S

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Montanari, N

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Navines, J

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Neumann, U P

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Peddu, P

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Primrose, J N

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Qu, X

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Raptis, D

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Ridouani, F

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Rogan, C

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Sallemi, C

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Moragues, J Sampere

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Sandström, P

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Sarriá, L

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Schnitzbauer, A

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Serenari, M

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Serrablo, A

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Smits, M L J

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Sutcliffe, R P

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Tancredi, I

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Tasse, J C

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Udupa, V

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Valenti, D

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Fundora, Y

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Vogl, T J

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Wang, X

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White, S A

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Wohlgemuth, W A

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Yu, D

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Zijlstra, I A J

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Binkert, C A

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Bemelmans, M H A

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van der Leij, C

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Schadde, E

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van Dam, R M

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1 September 2022

Korenblik, R

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Olij, B

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Aldrighetti, L A

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Hilal, M Abu

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Ahle, M

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Arslan, B

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van Baardewijk, L J

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Baclija, I

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Bent, C

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Bertrand, C L

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Björnsson, B

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de Boer, M T

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de Boer, S W

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Bokkers, R P H

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Rinkes, I H M Borel

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Breitenstein, S

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Camacho, J C

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Cappelli, A

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Carling, U

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Chan, B K Y

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Chang, D H

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Choi, J

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Croagh, D

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Cugat, E

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Davis, R

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De Boo, D W

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De Cobelli, F

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van Delden, O M

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Delle, M

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Detry, O

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Díaz-Nieto, R

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Dili, A

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Erdmann, J I

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Fisher, O

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Fondevila, C

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Fretland, Å

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Borobia, F Garcia

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Gelabert, A

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Gérard, L

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Giuliante, F

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Gobardhan, P D

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Gómez, F

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Grünberger, T

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Grünhagen, D J

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Guitart, J

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Hagendoorn, J

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Heil, J

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Heise, D

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Herrero, E

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Hess, G F

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Hoffmann, M H

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Iezzi, R

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Imani, F

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Nguyen, J

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Jovine, E

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Kalff, J C

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Kazemier, G

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Kleeff, J

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Kollmar, O

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Ben, S Lopez

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Lucidi, V

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MacDonald, A

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Madoff, D C

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Manekeller, S

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Martel, G

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Mehrabi, A

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Mehrzad, H

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Meijerink, M R

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Menon, K

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Metrakos, P

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Meyer, C

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Moelker, A

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Modi, S

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Montanari, N

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Navines, J

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Neumann, U P

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Peddu, P

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Primrose, J N

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Qu, X

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Raptis, D

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Ratti, F

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Ridouani, F

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Rogan, C

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Ronellenfitsch, U

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Ryan, S

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Sallemi, C

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Moragues, J Sampere

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Sandström, P

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Sarriá, L

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Schnitzbauer, A

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Serenari, M

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Serrablo, A

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Smits, M L J

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Sparrelid, E

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Spüntrup, E

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Stavrou, G A

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Sutcliffe, R P

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Tancredi, I

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Tasse, J C

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Udupa, V

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Valenti, D

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Fundora, Y

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Vogl, T J

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Wang, X

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White, S A

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Wohlgemuth, W A

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Yu, D

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Zijlstra, I A J

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Binkert, C A

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Bemelmans, M H A

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van der Leij, C

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Schadde, E

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van Dam, R M

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Korenblik, R, Olij, B, Aldrighetti, L A, Hilal, M Abu, 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 Borel, Breitenstein, S, Bruijnen, R C G, Bruners, P, Büchler, M W, Camacho, J C, Cappelli, A, Carling, U, Chan, B K Y, Chang, D H, Choi, J, Font, J Codina, Crawford, M, Croagh, D, Cugat, E, Davis, R, De Boo, D W, De Cobelli, F, De Wispelaere, J F, van Delden, O M, Delle, M, Detry, O, Díaz-Nieto, R, Dili, A, Erdmann, J I, Fisher, O, Fondevila, C, Fretland, Å, Borobia, F Garcia, Gelabert, A, Gérard, L, Giuliante, F, Gobardhan, P D, Gómez, F, Grünberger, T, Grünhagen, D J, Guitart, J, Hagendoorn, J, Heil, J, Heise, D, Herrero, E, Hess, G F, Hoffmann, M H, Iezzi, R, Imani, F, Nguyen, J, Jovine, E, Kalff, J C, Kazemier, G, Kingham, T P, Kleeff, J, Kollmar, O, Leclercq, W K G, Ben, S Lopez, Lucidi, V, MacDonald, A, Madoff, D C, Manekeller, S, Martel, G, Mehrabi, A, Mehrzad, H, Meijerink, M R, Menon, K, Metrakos, P, Meyer, C, Moelker, A, Modi, S, Montanari, N, Navines, J, Neumann, U P, Peddu, P, Primrose, J N, Qu, X, Raptis, D, Ratti, F, Ridouani, F, Rogan, C, Ronellenfitsch, U, Ryan, S, Sallemi, C, Moragues, J Sampere, Sandström, P, Sarriá, L, Schnitzbauer, A, Serenari, M, Serrablo, A, Smits, M L J, Sparrelid, E, Spüntrup, E, Stavrou, G A, Sutcliffe, R P, Tancredi, I, Tasse, J C, Udupa, V, Valenti, D, Fundora, Y, Vogl, T J, Wang, X, White, S A, Wohlgemuth, W A, Yu, D, Zijlstra, I A J, Binkert, C A, Bemelmans, M H A, van der Leij, C, Schadde, E and 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. (doi:10.1007/s00270-022-03176-1).

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Accepted/In Press date: 8 May 2022

Published date: 1 September 2022

Additional Information: 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).

Identifiers

Local EPrints ID: 469236

URI: http://eprints.soton.ac.uk/id/eprint/469236

DOI: doi:10.1007/s00270-022-03176-1

ISSN: 0174-1551

PURE UUID: e380dcc4-009f-430a-ab4d-9ba89b5c497d

ORCID for J N Primrose:

orcid.org/0000-0002-2069-7605

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Date deposited: 09 Sep 2022 16:47

Last modified: 17 Mar 2024 02:40

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Contributors

Author: R Korenblik

Author: B Olij

Author: L A Aldrighetti

Author: M Abu Hilal

Author: M Ahle

Author: B Arslan

Author: L J van Baardewijk

Author: I Baclija

Author: C Bent

Author: C L Bertrand

Author: B Björnsson

Author: M T de Boer

Author: S W de Boer

Author: R P H Bokkers

Author: I H M Borel Rinkes

Author: S Breitenstein

Author: R C G Bruijnen

Author: P Bruners

Author: M W Büchler

Author: J C Camacho

Author: A Cappelli

Author: U Carling

Author: B K Y Chan

Author: D H Chang

Author: J Choi

Author: J Codina Font

Author: M Crawford

Author: D Croagh

Author: E Cugat

Author: R Davis

Author: D W De Boo

Author: F De Cobelli

Author: J F De Wispelaere

Author: O M van Delden

Author: M Delle

Author: O Detry

Author: R Díaz-Nieto

Author: A Dili

Author: J I Erdmann

Author: O Fisher

Author: C Fondevila

Author: Å Fretland

Author: F Garcia Borobia

Author: A Gelabert

Author: L Gérard

Author: F Giuliante

Author: P D Gobardhan

Author: F Gómez

Author: T Grünberger

Author: D J Grünhagen

Author: J Guitart

Author: J Hagendoorn

Author: J Heil

Author: D Heise

Author: E Herrero

Author: G F Hess

Author: M H Hoffmann

Author: R Iezzi

Author: F Imani

Author: J Nguyen

Author: E Jovine

Author: J C Kalff

Author: G Kazemier

Author: T P Kingham

Author: J Kleeff

Author: O Kollmar

Author: W K G Leclercq

Author: S Lopez Ben

Author: V Lucidi

Author: A MacDonald

Author: D C Madoff

Author: S Manekeller

Author: G Martel

Author: A Mehrabi

Author: H Mehrzad

Author: M R Meijerink

Author: K Menon

Author: P Metrakos

Author: C Meyer

Author: A Moelker

Author: S Modi

Author: N Montanari

Author: J Navines

Author: U P Neumann

Author: P Peddu

Author: J N Primrose

Author: X Qu

Author: D Raptis

Author: F Ratti

Author: F Ridouani

Author: C Rogan

Author: U Ronellenfitsch

Author: S Ryan

Author: C Sallemi

Author: J Sampere Moragues

Author: P Sandström

Author: L Sarriá

Author: A Schnitzbauer

Author: M Serenari

Author: A Serrablo

Author: M L J Smits

Author: E Sparrelid

Author: E Spüntrup

Author: G A Stavrou

Author: R P Sutcliffe

Author: I Tancredi

Author: J C Tasse

Author: V Udupa

Author: D Valenti

Author: Y Fundora

Author: T J Vogl

Author: X Wang

Author: S A White

Author: W A Wohlgemuth

Author: D Yu

Author: I A J Zijlstra

Author: C A Binkert

Author: M H A Bemelmans

Author: C van der Leij

Author: E Schadde

Author: R M van Dam

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