학술논문
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
Document Type
Author
Korenblik, R.; Olij, B.; Aldrighetti, L. A.; Abu Hilal, M.; Ahle, Margareta, 1966; Arslan, B.; van Baardewijk, L. J.; Baclija, I; Bent, C.; Bertrand, C. L.; Björnsson, Bergthor, 1975; 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, 1965; 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.
Source
Cardiovascular and Interventional Radiology. 45:1391-1398
Subject
Language
English
ISSN
0174-1551
1432-086X
1432-086X
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.