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. 2022 Sep;45(9):1391-1398.
doi: 10.1007/s00270-022-03176-1. Epub 2022 Jul 5.

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  1   2 B Olij  3   4 L A Aldrighetti  5 M Abu Hilal  6 M Ahle  7 B Arslan  8 L J van Baardewijk  9 I Baclija  10 C Bent  11 C L Bertrand  12 B Björnsson  13 M T de Boer  14 S W de Boer  15 R P H Bokkers  16 I H M Borel Rinkes  17 S Breitenstein  18 R C G Bruijnen  19 P Bruners  20 M W Büchler  21 J C Camacho  22 A Cappelli  23 U Carling  24 B K Y Chan  25 D H Chang  26 J Choi  27 J Codina Font  28 M Crawford  29 D Croagh  30 E Cugat  31 R Davis  32 D W De Boo  33 F De Cobelli  34 J F De Wispelaere  35 O M van Delden  36 M Delle  37 O Detry  38 R Díaz-Nieto  25 A Dili  12 J I Erdmann  39 O Fisher  29 C Fondevila  40 Å Fretland  41 F Garcia Borobia  42 A Gelabert  43   44 L Gérard  45 F Giuliante  46 P D Gobardhan  47 F Gómez  48 T Grünberger  49 D J Grünhagen  50 J Guitart  44 J Hagendoorn  17 J Heil  51 D Heise  52 E Herrero  53 G F Hess  54 M H Hoffmann  55 R Iezzi  56 F Imani  57 J Nguyen  58 E Jovine  59 J C Kalff  60 G Kazemier  61 T P Kingham  62 J Kleeff  63 O Kollmar  54 W K G Leclercq  64 S Lopez Ben  65 V Lucidi  66 A MacDonald  67 D C Madoff  68 S Manekeller  60 G Martel  69 A Mehrabi  21 H Mehrzad  70 M R Meijerink  71 K Menon  72 P Metrakos  73 C Meyer  74 A Moelker  75 S Modi  76 N Montanari  77 J Navines  31 U P Neumann  4   52 P Peddu  78 J N Primrose  79 X Qu  80 D Raptis  81 F Ratti  5 F Ridouani  22 C Rogan  82 U Ronellenfitsch  63 S Ryan  83 C Sallemi  84 J Sampere Moragues  85 P Sandström  13 L Sarriá  86 A Schnitzbauer  51 M Serenari  87 A Serrablo  88 M L J Smits  19 E Sparrelid  89 E Spüntrup  90 G A Stavrou  91 R P Sutcliffe  92 I Tancredi  93 J C Tasse  8 V Udupa  94 D Valenti  95 Y Fundora  40 T J Vogl  96 X Wang  97 S A White  98 W A Wohlgemuth  99 D Yu  100 I A J Zijlstra  71 C A Binkert  101 M H A Bemelmans  4   52 C van der Leij  15 E Schadde #  18   102 R M van Dam #  103   104   105
Affiliations

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 et al. Cardiovasc Intervent Radiol. 2022 Sep.

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).

Keywords: Colorectal cancer liver metastases (CRLM); Combined portal- and hepatic vein embolization (PVE/HVE); Future liver remnant (FLR); Hepatic vein embolization (HVE); Liver hypertrophy; Portal vein embolization (PVE).

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
DRAGON 1 visit flowchart

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