Dataset Information

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.

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).

SUBMITTER: Korenblik R

PROVIDER: S-EPMC9458562 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

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.

Korenblik R R Olij B B Aldrighetti L A LA Hilal M Abu MA Ahle M M Arslan B B van Baardewijk L J LJ Baclija I I Bent C C Bertrand C L CL Björnsson B B de Boer M T MT de Boer S W SW Bokkers R P H RPH Rinkes I H M Borel IHMB Breitenstein S S Bruijnen R C G RCG Bruners P P Büchler M W MW Camacho J C JC Cappelli A A Carling U U Chan B K Y BKY Chang D H DH Choi J J Font J Codina JC Crawford M M Croagh D D Cugat E E Davis R R De Boo D W DW De Cobelli F F De Wispelaere J F JF van Delden O M OM Delle M M Detry O O Díaz-Nieto R R Dili A A Erdmann J I JI Fisher O O Fondevila C C Fretland Å Å Borobia F Garcia FG Gelabert A A Gérard L L Giuliante F F Gobardhan P D PD Gómez F F Grünberger T T Grünhagen D J DJ Guitart J J Hagendoorn J J Heil J J Heise D D Herrero E E Hess G F GF Hoffmann M H MH Iezzi R R Imani F F Nguyen J J Jovine E E Kalff J C JC Kazemier G G Kingham T P TP Kleeff J J Kollmar O O Leclercq W K G WKG Ben S Lopez SL Lucidi V V MacDonald A A Madoff D C DC Manekeller S S Martel G G Mehrabi A A Mehrzad H H Meijerink M R MR Menon K K Metrakos P P Meyer C C Moelker A A Modi S S Montanari N N Navines J J Neumann U P UP Peddu P P Primrose J N JN Qu X X Raptis D D Ratti F F Ridouani F F Rogan C C Ronellenfitsch U U Ryan S S Sallemi C C Moragues J Sampere JS Sandström P P Sarriá L L Schnitzbauer A A Serenari M M Serrablo A A Smits M L J MLJ Sparrelid E E Spüntrup E E Stavrou G A GA Sutcliffe R P RP Tancredi I I Tasse J C JC Udupa V V Valenti D D Fundora Y Y Vogl T J TJ Wang X X White S A SA Wohlgemuth W A WA Yu D D Zijlstra I A J IAJ Binkert C A CA Bemelmans M H A MHA van der Leij C C Schadde E E van Dam R M RM

Cardiovascular and interventional radiology 20220705 9

<h4>Study purpose</h4>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.<h4>Methods</h4>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 e ...[more]

PMID: 35790566

Similar Datasets

Project description:BackgroundIn patients undergoing major liver resection, portal vein embolization (PVE) has been widely used to induce hypertrophy of the non-embolized liver in order to prevent post-hepatectomy liver failure. PVE is a safe and effective procedure, but does not always lead to sufficient hypertrophy of the future liver remnant (FLR). Hepatic vein(s) embolization has been proposed to improve FLR regeneration when insufficient after PVE. The sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FLR but it implies two different procedures with no time gain as compared to PVE alone. We have developed the so-called liver venous deprivation (LVD), a combination of PVE and HVE during the same intervention, to optimize the phase of liver preparation before surgery. The main objective of this randomized phase II trial is to compare the percentage of change in FLR volume at 3 weeks after LVD or PVE.MethodsPatients eligible to this multicenter prospective randomized phase II study are subjects aged from 18 years old suffering from colo-rectal liver metastases considered as resectable and with non-cirrhotic liver parenchyma. The primary objective is the percentage of change in FLR volume at 3 weeks after LVD or PVE using MRI or CT-Scan. Secondary objectives are assessment of tolerance, post-operative morbidity and mortality, post-hepatectomy liver failure, rate of non-respectability due to insufficient FLR or tumor progression, per-operative difficulties, blood loss, R0 resection rate, post-operative liver volume and overall survival. Objectives of translational research studies are evaluation of pre- and post-operative liver function and determination of biomarkers predictive of liver hypertrophy. Sixty-four patients will be included (randomization ratio 1:1) to detect a difference of 12% at 21 days in FLR volumes between PVE and LVD.DiscussionAdding HVE to PVE during the same procedure is an innovative and promising approach that may lead to a rapid and major increase in volume and function of the FLR, thereby increasing the rate of resectable patients and limiting the risk of patient's drop-out.Trial registrationThis study was registered on clinicaltrials.gov on 15th February 2019 (NCT03841305).

Dataset Information

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.

Study purpose

Methods

Results

Conclusion

Trial registration

Publications

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.

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