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
Remon Korenblik, Bram Olij, Luca Aldrighetti, Mohammad Abu Hilal, Margareta Ahle, Bülent Arslan, Laurens J. van Baardewijk, Ivan Baclija, Clare Bent, Claude Bertrand, Bergþór Björnsson, Marieke T. de Boer, Sanne de Boer, Reinoud P.H. Bokkers, Inne H.M. Borel Rinkes, Stefan Breitenstein, Rutger C. G. Bruijnen, Philipp Bruners, Markus W. Büchler, Juan C. Camacho, Alberta Cappelli, Ulrik Carling, B Chan, De‐Hua Chang, Jin‐Su Choi, J Codina Font, Michael Crawford, Daniel Croagh, Esteban Cugat, R Davis, D. W. De Boo, Francesco De Cobelli, J F De Wispelaere, Otto M. van Delden, Martin Delle, Olivier Detry, Rafael Díaz-Nieto, Alexandra Dili, Joris I. Erdmann, Oliver M. Fisher, Constantino Fondevila, Åsmund Avdem Fretland, F. García Borobia, Arantxa Gelabert, Laurent Gérard, Felice Giuliante, Paul D. Gobardhan, Fernando Gómez, Thomas Grünberger, Dirk J. Grünhagen, J. Guitart, Jeroen Hagendoorn, Jan Heil, Daniel Heise, Eduardo Ferrero Herrero, Gabriel Fridolin Hess, Michael Hoffmann, Roberto Iezzi, Farshad Imani, J Nguyen, Elio Jovine, Jörg C. Kalff, Geert Kazemier, T. Peter Kingham, Jörg Kleeff, Otto Kollmar, Wouter K. G. Leclercq, S. Lopez Ben, Valério Lucidi, Andrew Macdonald, David C. Madoff, Steffen Manekeller, Guillaume Martel, Arianeb Mehrabi, Homoyoon Mehrzad, Martijn R. Meijerink, Krishna Menon, Peter Metrakos, Christian P. Meyer, Adriaan Moelker, Sachin Modi, Nicola Montanari, Jordi Navinés, Ulf P. Neumann, Praveen Peddu, John Primrose, Xu-Dong Qu, Dimitri Aristotle Raptis, Francesca Ratti, Fourat Ridouani, Christopher Rogan, Ulrich Ronellenfitsch, Sara Ryan, Claudio Sallemi, J. Sampere Moragues, Per Sandström, L. Sarriá, Andreas A. Schnitzbauer, Matteo Serenari, Alejandro Serrablo
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).