Colorectal Cancer Liver Metastases (CRLM) Cancer of the bowel that has spread to the liver.
Conditions
Interventions
Combined PVE/HVE is the occlusion of the portal vein branch of one side of the
liver complemented by the embolization of the hepatic veins draining the same
area, to induce hypertrophy on the contra
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with primarily unresectable or potentially resectable CRLM with an FLR <30% (<40% in chemotherapy-damaged livers). • Patients with non-resected primary colorectal cancer (CRC) may be included if there is an intention to resect the CRC after the liver treatment (liver-first approach) or simultaneously during one of the liver procedures. • Patients with resectable or ablatable lung or brain metastases can be included, provided that a statement about the resectability of these extrahepatic metastases by a tumour board is available. • 18 years and older. • Men and women. • Able to understand the trial and provide informed consent.
Exclusion criteria
Exclusion criteria: • Pregnant or lactating women. • Premenopausal females not able or willing to commit to contraception • Patients with prohibitive comorbidities, decision made by local team. • Any patient with non-resectable or non-ablatable extrahepatic disease. • Patients with hepatic malignancies other than CRLM. • Progression of disease according to RECIST criteria after cytoreductive chemotherapy. • Complete response after conversion chemotherapy. • Staging CT and (if indicated) CT/MRI of the brain demonstrating non-resectable extrahepatic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 5-year overall survival • Future Liver Remnant sufficient for resection in week 3 (based on liver volume) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Kinetic growth and volume of the FLR (efficacy assessment) • FLR function increase (LiMax, ICG clearance, Hepatobiliary scintigraphy, MRI-function) • VAS (post embolization and resection) • Time to sufficient FLR volume • Success rate of IR procedure Embolization performed as scheduled / achievement of hemostasis • Time from intervention to resection • Postembolization complications prior to surgery • Operation duration • Postoperative complications at 90 days • Mortality at 90 days • Survival at 1 year • Disease-free survival at 1 year • Number of oncological co-interventions (for example: resections, ablations, SIRT, Systemic theraphy, etcetera) during survival. • Quality of life • Economic evaluation • Etcetera* | — |
Countries
Australia, Austria, Belgium, Canada, Germany, Italy, Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactG.J. Malseed
Maastricht Universitair Medisch Centrum +
Outcome results
None listed