NCT07717437

Brief 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. This collaborative registry focuses on identifying associations between baseline clinical/imaging parameters, clinical outcomes, and safety for patients undergoing PVE/HVE.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
12 countries

30 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Mar 2021Nov 2032

Study Start

First participant enrolled

March 16, 2021

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2032

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

6.7 years

First QC Date

June 10, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Liver cancerLiver metastasesPortal vein embolizationPVEHVEPVE/HVEFuture liver remnantLiver resectionHepatectomyPost-hepatectomy liver failureSurgical oncologyDouble Vein EmbolisationFLRLiver Venous DeprivationLVDHepatic Vein EmbolizationHepatocellular CarcinomaPerihilar cholangiocarcinomaIntrahepatic cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

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

    From enrolment until 5 year follow up

Secondary Outcomes (10)

  • Number of complications during embolization

    Perioperative

  • Kinetic Growth Rate [%/week]

    3 weeks after the embolization

  • Functional Growth Rate [%/week]

    Three weeks after the embolization

  • 90-day survival after embolization

    90 days post-embolization / post-resection

  • Number of complications during surgery

    Perioperative

  • +5 more secondary outcomes

Study Arms (1)

PVE/HVE

This registry collects data on patients who have undergone combined portal and hepatic vein embolisation prior to major liver surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

MedUni Wien

Vienna, State of Vienna, 1090, Austria

RECRUITING

Social Center South (Klinik Favoriten)

Vienna, State of Vienna, 1100, Austria

RECRUITING

UZ Antwerpen

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Erasmus Hospital

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

CHU de Liège

Liège, Liège, 4000, Belgium

RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

University Hospital Aachen (Uniklinik RWTH Aachen)

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Klinikum Saarbrücken

Saarbrücken, Saarland, 66119, Germany

RECRUITING

Universitätsklinikum Halle

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

MUMC+

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

Leids Universitair Medisch Centrum

Leiden, South Holland, 2333, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

NOT YET RECRUITING

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

RECRUITING

Oslo University Hospital

Oslo, Oslo, 0424, Norway

RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, Barcelona, 08035, Spain

RECRUITING

Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

RECRUITING

University Hospital Linköping

Linköping, Östergötland County, 581 85, Sweden

RECRUITING

Klinik Hirslanden

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

Aintree University Hospital

Liverpool, Merseyside, L9 7AL, United Kingdom

RECRUITING

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, North East England, NE7 7DN, United Kingdom

RECRUITING

Queen Elizabeth Hospital

Birmingham, West Midlands, B15 2GW, United Kingdom

RECRUITING

Related Publications (8)

  • 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.

    PMID: 41676779BACKGROUND
  • 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.

    PMID: 39078494BACKGROUND
  • 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.

    PMID: 38662462BACKGROUND
  • 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.

    PMID: 36127520BACKGROUND
  • 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.

    PMID: 36437731BACKGROUND
  • 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.

    PMID: 35790566BACKGROUND
  • 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.

    PMID: 36680689BACKGROUND
  • 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.

    PMID: 33661306BACKGROUND

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, HepatocellularKlatskin TumorCholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Ronald Van Dam, Dr.

    Maastricht Universitair Medisch Centrum

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fenna Van der Zijden, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

July 21, 2026

Study Start

March 16, 2021

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2032

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations