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 D...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Study Protocol
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9458562/
https://www.ncbi.nlm.nih.gov/pubmed/35790566
http://dx.doi.org/10.1007/s00270-022-03176-1
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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.
van Dam, R. M.
author_facet 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_sort Korenblik, R.
collection PubMed
description 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). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00270-022-03176-1.
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spelling pubmed-94585622022-09-10 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. Cardiovasc Intervent Radiol Study Protocol 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). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00270-022-03176-1. Springer US 2022-07-05 2022 /pmc/articles/PMC9458562/ /pubmed/35790566 http://dx.doi.org/10.1007/s00270-022-03176-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Study Protocol
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.
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9458562/
https://www.ncbi.nlm.nih.gov/pubmed/35790566
http://dx.doi.org/10.1007/s00270-022-03176-1
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