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; 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; van Dam, R M

Author

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

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Publication date

2022-07-05

Subject

Oncology. Pathology.
Radiology
Surgery

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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).

Citation

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 Å, 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. 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. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1391-1398. doi: 10.1007/s00270-022-03176-1. Epub 2022 Jul 5

Type

Article