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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have undergone PVE/HVE or technical variations on this procedure

18 Years and older

Men and women

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

350 Participants
are grouped into 1 trial group
Group A: PVE/HVE

Trial outcomes

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

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

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
90 days post-embolization / post-resection

Other outcomes

Sponsors and contacts

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