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
Authors: 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. 
Published: July 2022

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).