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 ,J Sampere Moragues,M H A Bemelmans,B Olij,Jörg C Kalff ,Jeroen Hagendoorn ,Steve White ,Christopher Rogan ,J Guitart ,Francesca Ratti ,Daniel Croagh ,Guillaume Martel ,T Peter Kingham ,Martijn R Meijerink ,Rafael Díaz-Nieto ,Margareta Ahle ,Farshad Imani ,Gregor A Stavrou ,Elio Jovine ,Laurent Gérard ,R Davis ,I Baclija ,Dirk J Grünhagen ,Å.a Fretland ,Alexandra Dili ,J Nguyen ,Peter Metrakos ,Ulrich Ronellenfitsch ,Thomas Grünberger ,I Tancredi ,Nicola Montanari ,Venkatesha Udupa ,Esteban Cugat ,Fernando Gómez ,R Bruijnen ,Elmar Spüntrup ,Ulf Neumann ,Y Fundora,Beverley Chan ,Matteo Serenari ,Arantxa Gelabert ,Bülent Arslan ,Thomas Vogl ,Arianeb Mehrabi ,Eduardo Ferrero Herrero ,Bergþór Björnsson ,Xu‐Wen Wang ,Andrew Macdonald ,David Valenti ,Ij A J Zijlstra ,Michael Hoffmann ,Marieke T De Boer ,Santiago López Ben ,Francesco De Cobelli ,J Tasse ,Felice Giuliante ,Mohammad Abu Hilal ,Mark Smits ,J Codina Font ,Constantino Fondevila ,Laurens J Van Baardewijk ,C Bertrand ,Daniel Heise ,Xu-Dong Qu ,Paul D Gobardhan ,Walter A Wohlgemuth ,D Yu ,Sara Ryan ,Christoph A Binkert ,Olivier Detry ,Luca Aldrighetti ,J F De Wispelaere ,Christiaan Van Der Leij ,Juan C Camacho ,Markus W Büchler ,Adriaan Moelker ,Steffen Manekeller ,Jan Heil ,David C Madoff ,Per Sandström ,Philipp Bruners ,Clare Bent ,Krishna Menon ,Sanne W De Boer ,Reinoud P H Bokkers ,Inne H.m Borel Rinkes ,Praveen Peddu ,Jin‐Su Choi ,Valério Lucidi ,Jordi Navinés ,Wouter K G Leclercq ,Robert P Sutcliffe ,Otto Kollmar ,Claudio Sallemi ,Geert Kazemier ,Dimitri A Raptis ,Sachin Modi ,Christian Meyer ,Ernesto Sparrelid ,Alberta Cappelli ,Joerg Kleeff ,L Sarria ,Stefan Breitenstein ,Erik Schadde ,John Primrose ,Otto M Van Delden ,D W De Boo ,Ulrik Carling ,Fourat Ridouani ,Gabriel Fridolin Hess ,Francisco G Borobia ,Alejandro Serrablo ,Oliver M Fisher ,Andreas A Schnitzbauer ,Martin Delle ,Homoyoon Mehrzad ,De‐Hua Chang ,Joris I Erdmann ,Michael Crawford ,Roberto Iezzi ,Ronald M Van Dam

doi:10.1007/s00270-022-03176-1

Abstract

Study PurposeThe 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.MethodsThe 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.ResultsNot applicable.ConclusionDRAGON 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 RegistrationClinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).

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