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AzTrials

Liver CancerNCT07717437

DRAGON Registry - International Multicenter Registry and Medical Image Bank for Patients With Primarily Unresectable Liver Cancer or Liver Metastases That Underwent Combined Portal and Hepatic Vein Embolization (PVE/HVE) to Increase Future Liver Remnant Before Resection.

An observational study of Liver Cancer and Liver Metastases, run by Maastricht University Medical Center at 31 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The DRAGON registry aims to collect data on combined portal and hepatic vein embolization (PVE/HVE) for liver tumors, a technique expected to enhance liver regeneration compared to standard PVE. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer, Liver Metastases
How many people
350 participants
Where
31 sitesin 13 countries
Study dates
16 Mar 2021to 30 Nov 2032
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients with primarily unresectable / potentially resectable liver cancer or liver metastases, who are treated with combined embolization of both portal and hepatic veins (PVE/HVE) in order to increase future liver remnant before resection.

Who may be able to join

  • Patients who have undergone PVE/HVE or technical variations on this procedure
  • 18 Years and older
  • Men and women

Who cannot join

None listed.

Trial locations and contacts

31 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Fenna Van der Zijden, Dr. contact

+316 40911632

fenna.van.der.zijden@mumc.nl

31 sites in 13 countries

Netherlands5 sites, 5 recruiting

  • Amsterdam UMC

    Amsterdam, North Holland, 1105 AZ

    Fenna Van der Zijden, f.a.vanderzijden@amsterdamumc.nl

    Joris Erdmann, Dr.

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, Provincie Groningen, 9713 GZ

    Mireille Zwijnen, 050 361 6161, m.g.p.zwijnen@umcg.nl

    Suomi Fouraschen, Dr.

    Recruiting

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333

    Dries Braat, Dr., 071 526 9111, a.e.braat@lumc.nl

    Dries Braat, Dr.

    Recruiting

  • MUMC+

    Maastricht, Limburg, 6229HX

    Fenna Van der Zijden, Dr., +316 40911632, fenna.van.der.zijden@mumc.nl

    Ronald Van Dam, Dr.

    Recruiting

  • Erasmus MC

    Rotterdam, South Holland, 3015 GD

    Jessica Holster, (010) 704 0 704, j.holster@erasmusmc.nl

    Bas Groot-Koerkamp, Prof. Dr.

    Not yet recruiting

Other trials in Netherlands

Belgium4 sites, 4 recruiting

  • Erasmus Hospital

    Anderlecht, Brussels Capital, 1070

    Valerio Lucidi, Dr., +32 2 555 31 11, valerio.lucidi@erasme.ulb.ac.be

    Valerio Lucidi, Dr.

    Recruiting

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

    Axelle Belis, +32 3 821 30 00, Axelle.Belis@uza.be

    Thiery Chapelle, Prof. Dr.

    Recruiting

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

    Lynn Huyck, +32 9 332 21 11, Lynn.Huyck@uzgent.be

    Luís Abreu de Carvalho, Dr.

    Recruiting

  • CHU de Liège

    Liège, Liège, 4000

    Axelle Bertrand, +32 4 323 00 00, Axelle.Bertrand@chuliege.be

    Olivier Detry, Prof. Dr.

    Recruiting

Other trials in Belgium

United States3 sites, 3 recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Frannie Richards, +1 312-942-5000, frannie_l_richards@rush.edu

    Matthew Dixon, Dr.

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Federico Aucejo, Dr., +1 216-444-2200, patientexperienceccl@ccf.org

    Federico Aucejo, Dr.

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Yawen Dong, Dr., +1 507-284-2511, InternationalCollaborate@mayo.edu

    Recruiting

Other trials in United States

Canada3 sites, 3 recruiting

  • Juravinski Hospital and Cancer Centre

    Hamilton, Ontario, L8V 5C2

    Elisabeth Lo, +1 905-387-9495, loe3@mcmaster.ca

    Leyo Ruo, Dr.

    Recruiting

  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4

    Jennifer Kalil, +1 514-934-1934, Jennifer.kalil@mail.mcgill.ca

    Peter Metrakos, Prof. Dr.

    Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Zanna Vanterpool, +1 613-722-7000, zvanterpool@ohri.ca

    Guillaume Martel, Dr.

    Recruiting

Other trials in Canada

Germany3 sites, 3 recruiting

  • University Hospital Aachen (Uniklinik RWTH Aachen)

    Aachen, North Rhine-Westphalia, 52074

    0241 80-0 oder 80-84444, info@ukaachen.de

    Philipp Bruners, Prof. Dr.

    Recruiting

  • Universitätsklinikum Halle

    Halle, Saxony-Anhalt, 06120

    Jörg Kleeff, Prof. Dr., +49 345 5570, iuk@uk-halle.de

    Jorg Kleeff, Prof. Dr.

    Recruiting

  • Klinikum Saarbrücken

    Saarbrücken, Saarland, 66119

    Gregor Stavrou, Dr., +49 681 9630, info@klinikum-saarbruecken.de

    Gregor Stavrou, Dr.

    Recruiting

Other trials in Germany

United Kingdom3 sites, 3 recruiting

  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2GW

    Diana Hull, +44 121 627 2000, Diana.Hull@uhb.nhs.uk

    Robert Sutcliffe, Dr.

    Recruiting

  • Aintree University Hospital

    Liverpool, Merseyside, L9 7AL

    Jerry Mathew, +44 151 525 5980, Jerry.Mathew@liverpoolft.nhs.uk

    Giovanna Bretland, +44 151 525 5980, Giovanna.Bretland@liverpoolft.nhs.uk

    Recruiting

  • Newcastle upon Tyne Hospitals

    Newcastle upon Tyne, North East England, NE7 7DN

    Steve White, Prof. Dr., +44 191 233 6161, steve.white@ncl.ac.uk

    Steve White, Prof. Dr.

    Recruiting

Other trials in United Kingdom

Austria2 sites, 2 recruiting

  • MedUni Wien

    Vienna, State of Vienna, 1090

    Johannes Längle, Dr., +43 1 401600, aufnahmeverfahren@meduniwien.ac.at

    Johannes Längle, Dr.

    Recruiting

  • Social Center South (Klinik Favoriten)

    Vienna, State of Vienna, 1100

    Thomas Grünberger, Prof. Dr., +43 1 601910, kfn.post@gesundheitsverbund.at

    Thomas Grünberger, Prof. Dr.

    Recruiting

Other trials in Austria

Spain2 sites, 2 recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Jordi Navinés López, Prof. Dr., +34 934 65 12 00, uac.germanstrias@gencat.cat

    Jordi Navinés López, Prof. Dr.

    Recruiting

  • Vall d'Hebron University Hospital

    Barcelona, Barcelona, 08035

    Laura Vidal Piñeiro, Dr., +34 934 89 30 00, web@vallhebron.cat

    Laura Vidal Piñeiro, Dr.

    Recruiting

Other trials in Spain

Sweden2 sites, 2 recruiting

  • University Hospital Linköping

    Linköping, Östergötland County, 581 85

    Per Sandström, Dr., +46 10 103 00 00, per.sandstrom@liu.se

    Per Sandström, Dr.

    Recruiting

  • Karolinska University Hospital

    Stockholm, Stockholm County, 17176

    Soraya Bandeily, +46 8 123 700 00, soraya.bandeily@regionstockholm.se

    Ernsto Sparrelid, Dr.

    Recruiting

Other trials in Sweden

Australia1 site, 1 recruiting

  • Monash Medical Centre

    Clayton, Victoria, 3168

    Meenal Gupta, (03) 9594 6666, Meenal.Gupta@monashhealth.org

    Diederick De Boo, Dr.

    Recruiting

Other trials in Australia

New Zealand1 site, 1 recruiting

  • Auckland City Hospital

    Grafton, Auckland, 1023

    Rukshan Fernando, Dr., +64 9 367 0000, RukshanF@adhb.govt.nz

    Rukshan Fernando, Dr.

    Recruiting

Other trials in New Zealand

Norway1 site, 1 recruiting

  • Oslo University Hospital

    Oslo, Oslo, 0424

    Åsmund Fretland, Dr., +47 22 11 80 80, fretland@gmail.com

    Åsmund Fretland, Dr.

    Recruiting

Other trials in Norway

Switzerland1 site, 1 recruiting

  • Klinik Hirslanden

    Zurich, Canton of Zurich, 8032

    Erik Schadde, Dr., +41 44 387 21 11, erik.schadde@hin.ch

    Erik Schadde, Dr.

    Recruiting

Other trials in Switzerland

About this study

The DRAGON registry aims to collect data on combined portal and hepatic vein embolization (PVE/HVE) for liver tumors, a technique expected to enhance liver regeneration compared to standard PVE. This collaborative registry focuses on identifying associations between baseline clinical/imaging parameters, clinical outcomes, and safety for patients undergoing PVE/HVE.

Read the detailed description

Retrospective and prospective

Keywords
Liver cancer, Liver metastases, Portal vein embolization, PVE, HVE, PVE/HVE, Future liver remnant, Liver resection, Hepatectomy, Post-hepatectomy liver failure, Surgical oncology, Double Vein Embolisation, FLR, Liver Venous Deprivation, LVD, Hepatic Vein Embolization, Hepatocellular Carcinoma, Perihilar cholangiocarcinoma, Intrahepatic cholangiocarcinoma
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular, Klatskin Tumor, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07717437
Study groupRoleWhat they receive
PVE/HVEThis registry collects data on patients who have undergone combined portal and hepatic vein embolisation prior to major liver surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resectability three weeks after PVE/HVE and 5 years overall survival

    Measured: From enrolment until 5 year follow up

Secondary outcomes (10)

  1. Number of complications during embolization

    The number of complications occurring during liver embolization (e.g., spill to the future liver remnant).

    Measured: Perioperative

  2. Kinetic Growth Rate [%/week]

    Volumetric assessments are performed at baseline and three weeks after embolization. Changes in FLR volume will be standardized (sFLR) by calculating the ratio of the FLR to the Standardized Total Liver Volume (sTLV) using the Vauthey formula. The DH will be calculated as the percentage point difference in sFLR volume between baseline and three weeks after embolization. The KGR will then be derived from the DH, quantifying the weekly percentage volume increase observed between these measurements.

    Measured: 3 weeks after the embolization

  3. Functional Growth Rate [%/week]

    The Functional Growth Rate reflects the rate at which FLR function increases after embolization, as measured by hepatobiliary scintigraphy. FLR function is expressed in %/min/m2 at baseline and three weeks after embolization. The functional degree of hypertrophy (FDH-function) is the percentage point difference in FLR function between these time points, and the FGR is calculated by dividing the DH-function by the number of weeks elapsed.

    Measured: Three weeks after the embolization

  4. 90-day survival after embolization

    90-day survival is defined as the proportion of patients alive at 90 days after liver embolization, serving as a standard measure of short-term postoperative outcome and surgical safety.

    Measured: 90 days post-embolization / post-resection

  5. Number of complications during surgery

    The number of complications occurring during liver surgery (e.g., excessive blood loss and vascular or biliary injury).

    Measured: Perioperative

  6. 90 day survival after resection

    90-day survival is defined as the proportion of patients alive at 90 days after liver surgery, serving as a standard measure of short-term postoperative outcome and surgical safety.

    Measured: 90 days

  7. Clinical resection rates

    The clinical resection rate is defined as the proportion of patients who undergo liver resection among those who started embolization.

    Measured: Until MDT decision on resection (yes/no), approximately 3-6 weeks after the embolization

  8. Number of salvage procedures

    This outcome measure captures the proportion of patients in whom the FLR fails to reach a sufficient volume or function after the initial embolization procedure, and who therefore undergo an additional salvage intervention (e.g., repeat or completion embolization) to further promote FLR growth before resection can be considered

    Measured: Approximately 3-6 weeks after the embolization

  9. Number of participants with disease recurrence

    The proportion of patients who develop disease recurrence (locoregional or distant) during follow-up after liver resection.

    Measured: Until five years after the embolization/resection

  10. Number of oncological interventions during follow up

    The number of additional oncological interventions (e.g., chemotherapy, repeat liver resection, ablation, radiotherapy) administered to patients during follow-up

    Measured: Until five years after the embolization/resection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start16 Mar 2021
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
350 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07717437
Sponsor's protocol ID
2021-2578
Status last verified
Jul 2026
First submitted
10 Jun 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • James S, van der Leij C, van Dam RM, Detry O. Liver venous deprivation before major hepatectomy-promising but still a work in progress. Hepatobiliary Surg Nutr. 2026 Feb 1;15(1):10. doi: 10.21037/hbsn-2025-560. Epub 2026 Jan 12. No abstract available.

    PubMed 41676779

  • James S, Smits J, van der Velden AL, Simon SR, Korenblik R, Dewulf MJL, van Dam RM, van der Leij C; DRAGON Trials Collaborative. Invited Commentary on "CIRSE Standards of Practice on Portal Vein Embolization and Double Vein Embolization/Liver Venous Deprivation". Cardiovasc Intervent Radiol. 2024 Sep;47(9):1311-1312. doi: 10.1007/s00270-024-03815-9. Epub 2024 Jul 29. No abstract available.

    PubMed 39078494

  • Korenblik R, Heil J, Smits J, James S, Olij B, Bechstein WO, Bemelmans MHA, Binkert CA, Breitenstein S, Williams M, Detry O, Dewulf MJL, Dili A, Grochola LF, Grote J, Heise D, Kalil JA, Metrakos P, Neumann UP, Pappas SG, Pennetta F, Schnitzbauer AA, Tasse JC, Winkens B, Olde Damink SWM, van der Leij C, Schadde E, van Dam RM; DRAGON trials collaborative. Liver regeneration after portal and hepatic vein embolization improves overall survival compared with portal vein embolization alone: mid-term survival analysis of the multicentre DRAGON 0 cohort. Br J Surg. 2024 Apr 3;111(4):znae087. doi: 10.1093/bjs/znae087.

    PubMed 38662462

  • Korenblik R, van der Leij C, van Dam RM. Reply to: Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant Hypertrophy-The Road Towards Level One Evidence. Cardiovasc Intervent Radiol. 2023 Jan;46(1):166-167. doi: 10.1007/s00270-022-03271-3. Epub 2022 Sep 20. No abstract available.

    PubMed 36127520

  • Korenblik R, van Zon JFJA, Olij B, Heil J, Dewulf MJL, Neumann UP, Olde Damink SWM, Binkert CA, Schadde E, van der Leij C, van Dam RM; DRAGON Trials Collaborative. Resectability of bilobar liver tumours after simultaneous portal and hepatic vein embolization versus portal vein embolization alone: meta-analysis. BJS Open. 2022 Nov 2;6(6):zrac141. doi: 10.1093/bjsopen/zrac141.

    PubMed 36437731

  • Korenblik R, Olij B, Aldrighetti LA, Hilal MA, Ahle M, Arslan B, van Baardewijk LJ, Baclija I, Bent C, Bertrand CL, Bjornsson B, de Boer MT, de Boer SW, Bokkers RPH, Rinkes IHMB, Breitenstein S, Bruijnen RCG, Bruners P, Buchler MW, Camacho JC, Cappelli A, Carling U, Chan BKY, Chang DH, Choi J, Font JC, Crawford M, Croagh D, Cugat E, Davis R, De Boo DW, De Cobelli F, De Wispelaere JF, van Delden OM, Delle M, Detry O, Diaz-Nieto R, Dili A, Erdmann JI, Fisher O, Fondevila C, Fretland A, Borobia FG, Gelabert A, Gerard L, Giuliante F, Gobardhan PD, Gomez F, Grunberger T, Grunhagen DJ, Guitart J, Hagendoorn J, Heil J, Heise D, Herrero E, Hess GF, Hoffmann MH, Iezzi R, Imani F, Nguyen J, Jovine E, Kalff JC, Kazemier G, Kingham TP, Kleeff J, Kollmar O, Leclercq WKG, Ben SL, Lucidi V, MacDonald A, Madoff DC, Manekeller S, Martel G, Mehrabi A, Mehrzad H, Meijerink MR, Menon K, Metrakos P, Meyer C, Moelker A, Modi S, Montanari N, Navines J, Neumann UP, Peddu P, Primrose JN, Qu X, Raptis D, Ratti F, Ridouani F, Rogan C, Ronellenfitsch U, Ryan S, Sallemi C, Moragues JS, Sandstrom P, Sarria L, Schnitzbauer A, Serenari M, Serrablo A, Smits MLJ, Sparrelid E, Spuntrup E, Stavrou GA, Sutcliffe RP, Tancredi I, Tasse JC, Udupa V, Valenti D, Fundora Y, Vogl TJ, Wang X, White SA, Wohlgemuth WA, Yu D, Zijlstra IAJ, Binkert CA, Bemelmans MHA, van der Leij C, Schadde E, van Dam RM. 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. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1391-1398. doi: 10.1007/s00270-022-03176-1. Epub 2022 Jul 5.

    PubMed 35790566

  • Chang X, Korenblik R, Olij B, Knapen RRMM, van der Leij C, Heise D, den Dulk M, Neumann UP, Schaap FG, van Dam RM, Olde Damink SWM. Influence of cholestasis on portal vein embolization-induced hypertrophy of the future liver remnant. Langenbecks Arch Surg. 2023 Jan 21;408(1):54. doi: 10.1007/s00423-023-02784-w.

    PubMed 36680689

  • Heil J, Korenblik R, Heid F, Bechstein WO, Bemelmans M, Binkert C, Bjornsson B, Breitenstein S, Detry O, Dili A, Dondelinger RF, Gerard L, Gimenez-Maurel T, Guiu B, Heise D, Hertl M, Kalil JA, Klein JJ, Lakoma A, Neumann UP, Olij B, Pappas SG, Sandstrom P, Schnitzbauer A, Serrablo A, Tasse J, Van der Leij C, Metrakos P, Van Dam R, Schadde E. Preoperative portal vein or portal and hepatic vein embolization: DRAGON collaborative group analysis. Br J Surg. 2021 Jul 23;108(7):834-842. doi: 10.1093/bjs/znaa149.

    PubMed 33661306

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cancer and Liver Metastases, run by Maastricht University Medical Center at 31 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Netherlands, Belgium, United States, Canada, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fenna Van der Zijden, Dr. (+316 40911632, fenna.van.der.zijden@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resectability three weeks after PVE/HVE and 5 years overall survival (time frame: From enrolment until 5 year follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07717437, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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