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
(2022) Cardiovascular and Interventional Radiology, volume 45, issue 9, pp. 1391 - 1398
(Article)
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.
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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).
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Keywords: Accreditation, Embolization, Therapeutic/methods, Hepatectomy/methods, Hepatic Veins/pathology, Hepatomegaly, Humans, Hypertrophy/etiology, Liver Neoplasms/diagnostic imaging, Liver/surgery, Multicenter Studies as Topic, Portal Vein/pathology, Prospective Studies, Treatment Outcome, Portal vein embolization (PVE), Colorectal cancer liver metastases (CRLM), Liver hypertrophy, Future liver remnant (FLR), Combined portal- and hepatic vein embolization (PVE/HVE), Hepatic vein embolization (HVE), Cardiology and Cardiovascular Medicine, Radiology Nuclear Medicine and imaging, Journal Article
ISSN: 0174-1551
Publisher: Springer-Verlag
Note: Funding Information: The Dutch Cancer Society (KWF), Maastricht University Medical Center, NIHR, Guerbet, and Abbott Laboratories provided unrestricted financial support for monitoring, coordination and the infrastructure of this trial. All funders do not interfere with the initiation, coordination, analyzation, or publication of the results. Maastricht University is the sponsor of the DRAGON 1 trial. Publisher Copyright: © 2022, The Author(s).
(Peer reviewed)
