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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

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., 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.

Published
2022
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2. Dragon 1 Protocol Manuscript

Author

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, Å. 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, UCL - SSS/IREC/IMAG - Pôle d'imagerie médicale, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service de chirurgie, UCL - (MGD) Service de radiologie - résonance magnétique, ​Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), RS: GROW - R2 - Basic and Translational Cancer Biology, Surgery, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: Carim - B06 Imaging, MUMC+: MA Heelkunde (9), CCA - Cancer Treatment and quality of life, Radiology and nuclear medicine, ACS - Pulmonary hypertension & thrombosis, Radiology & Nuclear Medicine, Radiology and Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA -Cancer Center Amsterdam, CCA - Cancer Treatment and Quality of Life, ANS - Cellular & Molecular Mechanisms, ANS - Neuroinfection & -inflammation, ACS - Microcirculation, ANS - Neurovascular Disorders, ANS - Systems & Network Neuroscience, 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

Subjects
Liver hypertrophy, Portal vein embolization (PVE), Hepatic Veins, Accreditation, MAJOR HEPATECTOMY, SDG 3 - Good Health and Well-being, Combined portal- and hepatic vein embolization (PVE, MULTIPLE, Hepatectomy, Humans, Multicenter Studies as Topic, Radiology, Nuclear Medicine and imaging, Cardiac and Cardiovascular Systems, Prospective Studies, HEPATOBILIARY SCINTIGRAPHY, Combined portal- and hepatic vein embolization (PVE/HVE), Kardiologi, Portal Vein, Liver Neoplasms, Colorectal cancer liver metastases (CRLM), Hepatic vein embolization (HVE), HVE), Future liver remnant (FLR), Hypertrophy, Embolization, Therapeutic, 2-STAGE HEPATECTOMY, VENOUS DEPRIVATION, Treatment Outcome, Liver, COMPLETE RESECTION, Cardiology and Cardiovascular Medicine, Hepatomegaly
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).

Published
2022

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