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 DRA...

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Detalles Bibliográficos
Autores: Korenblik, R, Olij, B, Aldrighetti, LA, Abu Hilal, M, Ahle, M, Arslan, B, van Baardewijk, LJ, Baclija, I, Bent, C, Bertrand, CL, Bjornsson, B, de Boer, MT, de Boer, SW, Bokkers, RPH, Rinkes, IHMB, Breitenstein, S, Bruijnen, RCG, Bruners, P, Camacho, JC, Cappelli, A, Carling, U, Chan, BKY, Chang, DH, Choi, J, Font, JC, Crawford, M, Croagh, D, Cugat, E, Davis, R, De Boo, DW, De Cobelli, F, De Wispelaere, JF, van Delden, OM, Delle, M, Detry, O, Dili, A, Erdmann, JI, Fisher, O, Fondevila, C, Fretland, A, Borobia, FG, Gelabert, A, Gerard, L, Giuliante, F, Gobardhan, PD, Gomez, F, Grunberger, T, Grunhagen, DJ, Guitart, J, Hagendoorn, J, Heil, J, Heise, D, Herrero, E, Hess, GF, Hoffmann, MH, Iezzi, R, Imani, F, Nguyen, J, Jovine, E, Kalff, JC, Kazemier, G, Kingham, TP, Kleeff, J, Kollmar, O, Leclercq, WKG, Ben, SL, Lucidi, V, MacDonald, A, Madoff, DC, Manekeller, S, Martel, G, Mehrabi, A, Mehrzad, H, Meijerink, MR, Menon, K, Metrakos, P, Meyer, C, Moelker, A, Modi, S, Montanari, N, Navines, J, Neumann, UP, Peddu, P, Primrose, JN, Qu, X, Raptis, D, Ratti, F, Ridouani, F, Rogan, C, Ronellenfitsch, U, Ryan, S, Sallemi, C, Moragues, JS, Sandstrom, P, Sarria, L, Schnitzbauer, A, Serenari, M, Serrablo, A, Smits, MLJ, Sparrelid, E, Spuntrup, E, Stavrou, GA, Sutcliffe, RP, Tancredi, I, Tasse, JC, Udupa, V, Valenti, D, Fundora, Y, Vogl, TJ, Wang, X, White, SA, Wohlgemuth, WA, Yu, D, Zijlstra, IAJ, Binkert, CA, Bemelmans, MHA, van der Leij, C, Schadde, E, van Dam, RM
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p1310
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/1310
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85133472396&doi=10.1007%2fs00270-022-03176-1&partnerID=40&md5=aa5a31f15a6d78815dd887372760d5d3
Access Level:acceso abierto
Palabra clave:Colorectal cancer liver metastases (CRLM)
Portal vein embolization (PVE)
Hepatic vein embolization (HVE)
Combined portal- and hepatic vein embolization (PVE
HVE)
Liver hypertrophy
Future liver remnant (FLR)
Descripción
Sumario: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.

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