1. Colorectal cancer liver metastases (CRLM) 2.
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria • Patients with primarily unresectable/potentially resectable CRLM after conversion chemotherapy with a FLR
Exclusion criteria
Exclusion criteria: Exclusion criteria • Patients with extrahepatic disease other than lung metastases • Patients with metastatic disease to the lung that cannot be ablated or resected will be excluded • Patients with intrahepatic Cholangiocarcinoma (IHCC) • Patients with Perihilar Cholangiocarcinoma (PHCC) • Patients with Hepatocellular Carcinoma (HCC) • Pregnant or lactating women will be excluded. Women in conceiving age are required to take contraceptives or have to provide documentation of other means of contraception to be enrolled. • Progression by modified RECIST criteria on cross-sectional imaging after conversion chemotherapy is an exclusion criterion. • Complete response in cross-sectional imaging after conversion chemotherapy, which is certainly a rare event
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Demonstrate ability of center to enroll 3 patients in 12 months safely | — |
Secondary
| Measure | Time frame |
|---|---|
| • Efficacy assessment of hypertrophy induced • Assessment of variety of techniques - LVD vs. Double vein embolization vs. staged PVE/HVE • Feasibility assessment (proceeding to resection) • Safety of PVE/HVE (mortality/ morbidity) • Oncological effectiveness of PVE/HVE (recurrence/progression | — |
Countries
Netherlands