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Dragon 1 Protocol Manuscript
- Source :
- Cardiovascular and interventional radiology, (2022), Cardiovascular and interventional radiology, 45. SPRINGER, Cardiovascular and Interventional Radiology, 45(9), 1391-1398. Springer, Cham, CardioVascular and Interventional Radiology, 45(9), 1391-1398. Springer Verlag, Korenblik, R, Olij, B, Aldrighetti, L A, Hilal, M A, 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 B, 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 C, 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, Borobia, F G, 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 L, 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 S, 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 2022, ' 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 ', CardioVascular and Interventional Radiology, vol. 45, no. 9, pp. 1391-1398 . https://doi.org/10.1007/s00270-022-03176-1, CardioVascular and Interventional Radiology, 45(9), 1391-1398. Springer-Verlag, Cardiovascular and interventional radiology, 45(9), 1391-1398. Springer Verlag, CardioVascular and Interventional Radiology, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol, instname
- Publication Year :
- 2022
- Publisher :
- SPRINGER, 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. Trial Registration Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 01741551
- Volume :
- 45
- Database :
- OpenAIRE
- Journal :
- Cardiovascular and interventional radiology
- Accession number :
- edsair.doi.dedup.....2b65aeeb727716a92c8fb529fac700c9
- Full Text :
- https://doi.org/10.1007/s00270-022-03176-1