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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

Authors :
Korenblik, R.
Olij, B.
Aldrighetti, L. A.
Abu Hilal, M.
Ahle, Margareta
Arslan, B.
van Baardewijk, L. J.
Baclija, I
Bent, C.
Bertrand, C. L.
Björnsson, Bergthor
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.
Camacho, J. C.
Cappelli, A.
Carling, U.
Chan, B. K. Y.
Chang, D. H.
Choi, J.
Codina Font, J.
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.
Dili, A.
Erdmann, J. I
Fisher, O.
Fondevila, C.
Fretland, A.
Garcia Borobia, F.
Gelabert, A.
Gerard, L.
Giuliante, F.
Gobardhan, P. D.
Gomez, F.
Grunberger, T.
Grunhagen, 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.
Lopez Ben, S.
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.
Sampere Moragues, J.
Sandström, Per A
Sarria, L.
Schnitzbauer, A.
Serenari, M.
Serrablo, A.
Smits, M. L. J.
Sparrelid, E.
Spuntrup, 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.
Korenblik, R.
Olij, B.
Aldrighetti, L. A.
Abu Hilal, M.
Ahle, Margareta
Arslan, B.
van Baardewijk, L. J.
Baclija, I
Bent, C.
Bertrand, C. L.
Björnsson, Bergthor
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.
Camacho, J. C.
Cappelli, A.
Carling, U.
Chan, B. K. Y.
Chang, D. H.
Choi, J.
Codina Font, J.
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.
Dili, A.
Erdmann, J. I
Fisher, O.
Fondevila, C.
Fretland, A.
Garcia Borobia, F.
Gelabert, A.
Gerard, L.
Giuliante, F.
Gobardhan, P. D.
Gomez, F.
Grunberger, T.
Grunhagen, 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.
Lopez Ben, S.
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.
Sampere Moragues, J.
Sandström, Per A
Sarria, L.
Schnitzbauer, A.
Serenari, M.
Serrablo, A.
Smits, M. L. J.
Sparrelid, E.
Spuntrup, 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.
Publication Year :
2022

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.<br />Funding Agencies|Dutch Cancer Society (KWF); Abbott Laboratories; Maastricht University; Maastricht University Medical Center; NIHR; Guerbet

Details

Database :
OAIster
Notes :
application/pdf, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1346283993
Document Type :
Electronic Resource
Full Text :
https://doi.org/10.1007.s00270-022-03176-1
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