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.
Retrospective and prospective
Study Type
OBSERVATIONAL
Enrollment
350
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGMonash Medical Centre
Clayton, Victoria, Australia
RECRUITINGMedUni Wien
Vienna, State of Vienna, Austria
RECRUITINGSocial Center South (Klinik Favoriten)
Vienna, State of Vienna, Austria
RECRUITINGUZ Antwerpen
Edegem, Antwerpen, Belgium
RECRUITINGErasmus Hospital
Anderlecht, Brussels Capital, Belgium
RECRUITINGCHU de Liège
Liège, Liège, Belgium
RECRUITINGUZ Gent
Ghent, Oost-Vlaanderen, Belgium
RECRUITING...and 21 more locations
Resectability three weeks after PVE/HVE and 5 years overall survival
Time frame: From enrolment until 5 year follow up
Number of complications during embolization
The number of complications occurring during liver embolization (e.g., spill to the future liver remnant).
Time frame: Perioperative
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
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
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
Number of complications during surgery
The number of complications occurring during liver surgery (e.g., excessive blood loss and vascular or biliary injury).
Time frame: Perioperative
90 day survival after resection
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.
Time frame: 90 days
Clinical resection rates
The clinical resection rate is defined as the proportion of patients who undergo liver resection among those who started embolization.
Time frame: Until MDT decision on resection (yes/no), approximately 3-6 weeks after the embolization
Number of salvage procedures
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
Time frame: Approximately 3-6 weeks after the embolization
Number of participants with disease recurrence
The proportion of patients who develop disease recurrence (locoregional or distant) during follow-up after liver resection.
Time frame: Until five years after the embolization/resection
Number of oncological interventions during follow up
The number of additional oncological interventions (e.g., chemotherapy, repeat liver resection, ablation, radiotherapy) administered to patients during follow-up
Time frame: Until five years after the embolization/resection
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