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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Resectability three weeks after PVE/HVE and 5 years overall survival
Secondary outcomes
Number of complications during embolization
The number of complications occurring during liver embolization (e.g., spill to the future liver remnant).
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.
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.
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.
Sponsors and contacts
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