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Recruiting NCT07717437

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.

— Observational Liver Cancer Liver Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Liver Cancer, Liver Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Belgium, Canada +8
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Retrospective and prospective

Primary outcome measures

  • Resectability three weeks after PVE/HVE and 5 years overall survival [Time frame: From enrolment until 5 year follow up]
Secondary outcome measures (10)
  • Number of complications during embolization [Time frame: Perioperative]
  • Kinetic Growth Rate [%/week] [Time frame: 3 weeks after the embolization]
  • Functional Growth Rate [%/week] [Time frame: Three weeks after the embolization]
  • 90-day survival after embolization [Time frame: 90 days post-embolization / post-resection]
  • Number of complications during surgery [Time frame: Perioperative]
  • 90 day survival after resection [Time frame: 90 days]
  • Clinical resection rates [Time frame: Until MDT decision on resection (yes/no), approximately 3-6 weeks after the embolization]
  • Number of salvage procedures [Time frame: Approximately 3-6 weeks after the embolization]
  • Number of participants with disease recurrence [Time frame: Until five years after the embolization/resection]
  • Number of oncological interventions during follow up [Time frame: Until five years after the embolization/resection]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 5 centers
  • MUMC+ — Maastricht
  • Amsterdam UMC — Amsterdam
  • Universitair Medisch Centrum Groningen — Groningen
  • Leids Universitair Medisch Centrum — Leiden
  • Erasmus MC — Rotterdam
Belgium · 4 centers
  • UZ Antwerpen — Edegem
  • Erasmus Hospital — Anderlecht
  • CHU de Liège — Liège
  • UZ Gent — Ghent
United States · 3 centers
  • Rush University Medical Center — Chicago
  • Mayo Clinic — Rochester
  • Cleveland Clinic — Cleveland
Canada · 3 centers
  • Juravinski Hospital and Cancer Centre — Hamilton
  • The Ottawa Hospital — Ottawa
  • McGill University Health Centre — Montreal
Germany · 3 centers
  • University Hospital Aachen (Uniklinik RWTH Aachen) — Aachen
  • Klinikum Saarbrücken — Saarbrücken
  • Universitätsklinikum Halle — Halle
United Kingdom · 3 centers
  • Aintree University Hospital — Liverpool
  • Newcastle upon Tyne Hospitals — Newcastle upon Tyne
  • Queen Elizabeth Hospital — Birmingham
Austria · 2 centers
  • MedUni Wien — Vienna
  • Social Center South (Klinik Favoriten) — Vienna
Spain · 2 centers
  • Hospital Universitari Germans Trias i Pujol — Badalona
  • Vall d'Hebron University Hospital — Barcelona
Sweden · 2 centers
  • Karolinska University Hospital — Stockholm
  • University Hospital Linköping — Linköping
Australia · 1 center
  • Monash Medical Centre — Clayton
New Zealand · 1 center
  • Auckland City Hospital — Grafton
Norway · 1 center
  • Oslo University Hospital — Oslo
Switzerland · 1 center
  • Klinik Hirslanden — Zurich

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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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 PMID 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. PMID 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 embo PMID 33661306

Identifiers

NCT: NCT07717437 · 2021-2578

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗