Liver Cancer, Liver Metastases
Conditions
Keywords
Liver cancer, Liver metastases, Portal vein embolization, PVE, HVE, PVE/HVE, Future liver remnant, Liver resection, Hepatectomy, Post-hepatectomy liver failure, Surgical oncology, Double Vein Embolisation, FLR, Liver Venous Deprivation, LVD, Hepatic Vein Embolization, Hepatocellular Carcinoma, Perihilar cholangiocarcinoma, Intrahepatic cholangiocarcinoma
Brief summary
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
Interventions
None listed
Sponsors
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have undergone PVE/HVE or technical variations on this procedure * 18 Years and older * Men and women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resectability three weeks after PVE/HVE and 5 years overall survival | From enrolment until 5 year follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of complications during embolization | Perioperative | The number of complications occurring during liver embolization (e.g., spill to the future liver remnant). |
| Kinetic Growth Rate [%/week] | 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. |
| Functional Growth Rate [%/week] | 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. |
| 90-day survival after embolization | 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. |
| Number of complications during surgery | Perioperative | The number of complications occurring during liver surgery (e.g., excessive blood loss and vascular or biliary injury). |
| 90 day survival after resection | 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. |
| Clinical resection rates | 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. |
| Number of salvage procedures | 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 |
| Number of participants with disease recurrence | Until five years after the embolization/resection | The proportion of patients who develop disease recurrence (locoregional or distant) during follow-up after liver resection. |
| Number of oncological interventions during follow up | 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 |
Countries
Australia, Austria, Belgium, Canada, Germany, Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
CONTACTFenna Van der Zijden, Dr.
PRINCIPAL_INVESTIGATORRonald Van Dam, Dr.
Maastricht Universitair Medisch Centrum
Outcome results
None listed