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

R Korenblik*, B Olij, L A Aldrighetti, M Abu Hilal, M Ahle, B Arslan, L J van Baardewijk, I Baclija, C Bent, C L Bertrand, B Björnsson, M T de Boer, S W de Boer, R P H Bokkers, I H M Borel Rinkes, S Breitenstein, R C G Bruijnen, P Bruners, M W Büchler, J C CamachoA Cappelli, U Carling, B K Y Chan, D H Chang, J Choi, J Codina Font, M Crawford, D Croagh, E Cugat, R Davis, D W De Boo, F De Cobelli, J F De Wispelaere, O M van Delden, M Delle, O Detry, R Díaz-Nieto, A Dili, J I Erdmann, O Fisher, C Fondevila, Å Fretland, F Garcia Borobia, A Gelabert, L Gérard, F Giuliante, P D Gobardhan, F Gómez, T Grünberger, D J Grünhagen, J Guitart, J Hagendoorn, J Heil, D Heise, E Herrero, G F Hess, M H Hoffmann, R Iezzi, F Imani, J Nguyen, E Jovine, J C Kalff, G Kazemier, T P Kingham, J Kleeff, O Kollmar, W K G Leclercq, S Lopez Ben, V Lucidi, A MacDonald, D C Madoff, S Manekeller, G Martel, A Mehrabi, H Mehrzad, M R Meijerink, K Menon, P Metrakos, C Meyer, A Moelker, S Modi, N Montanari, J Navines, U P Neumann, P Peddu, J N Primrose, X Qu, D Raptis, F Ratti, F Ridouani, C Rogan, U Ronellenfitsch, S Ryan, C Sallemi, J Sampere Moragues, P Sandström, L Sarriá, A Schnitzbauer, M Serenari, A Serrablo, M L J Smits, E Sparrelid, E Spüntrup, G A Stavrou, R P Sutcliffe, I Tancredi, J C Tasse, V Udupa, D Valenti, Y Fundora, T J Vogl, X Wang, S A White, W A Wohlgemuth, D Yu, I A J Zijlstra, C A Binkert, M H A Bemelmans, C van der Leij, E Schadde, R M van Dam*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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).

Original languageEnglish
Pages (from-to)1391-1398
Number of pages8
JournalCardiovascular and Interventional Radiology
Volume45
Issue number9
Early online date5 Jul 2022
DOIs
Publication statusPublished - Sept 2022

Keywords

  • 2-STAGE HEPATECTOMY
  • COMPLETE RESECTION
  • Colorectal cancer liver metastases (CRLM)
  • Combined portal- and hepatic vein embolization (PVE
  • Future liver remnant (FLR)
  • HEPATOBILIARY SCINTIGRAPHY
  • HVE)
  • Hepatic vein embolization (HVE)
  • Liver hypertrophy
  • MAJOR HEPATECTOMY
  • MULTIPLE
  • Portal vein embolization (PVE)
  • VENOUS DEPRIVATION

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