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NCT Number: 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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Monash Medical Centre, Clayton, Victoria, Australia

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About this study

Retrospective and prospective

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: From enrolment until 5 year follow up

Secondary outcomes

  1. Number of complications during embolization

    Time frame: Perioperative

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

  2. Kinetic Growth Rate [%/week]

    Time frame: 3 weeks after the embolization

    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.

  3. Functional Growth Rate [%/week]

    Time frame: Three weeks after the embolization

    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.

  4. 90-day survival after embolization

    Time frame: 90 days post-embolization / post-resection

    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.

  5. Number of complications during surgery

    Time frame: Perioperative

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

  6. 90 day survival after resection

    Time frame: 90 days

    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.

  7. Clinical resection rates

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

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

  8. Number of salvage procedures

    Time frame: Approximately 3-6 weeks after the embolization

    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

  9. Number of participants with disease recurrence

    Time frame: Until five years after the embolization/resection

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

  10. Number of oncological interventions during follow up

    Time frame: Until five years after the embolization/resection

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fenna Van der Zijden, Dr.

CONTACT

[email protected]

+316 40911632

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2032
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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