irresectabel colorectal livermetastases, colorectale levermetastasen
Conditions
Interventions
Percutaneous isolated hepatic perfusion/chemosaturation of the liver
The principle of IHP is to shut the liver off of the systemic circulation by performing an operation. Subsequently the liver is flushed for an hour with a very high dose of chemotherapy, which would b
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: - Liver metastases of histologically confirmed primary colorectal adenocarcinoma; - Resection of primary tumor > 1 month before IHP; - Irresectable metastases confined to the liver based on CT-Thorax/abdomen and PET imaging; - Metastases measurable on CT-scan; - Informed consent; - Life expectancy > 4 months; - Leukocytes ≥ 3.0 X 10^9/L; - Thrombocytes ≥ 100 X 10^9/L; - Creatinine clearance ≥ 40 ml/min; - Bilirubin <17 µmol/L; - APTT < 32.5 sec; - PT < 13.7 sec;
Exclusion criteria
Exclusion criteria: Biological age 65 years - WHO performance status ≥ 2 (Appendix A); - < 40% healthy liver tissue; - Aberrant vascular anatomy, which impedes IHP (e.g. aberrant right or left hepatic artery, severe atherosclerosis, vascular dissections); - Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections, other liver disease); - Incompetent / Mentally disabled; - Pregnancy, inadequate anticonception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Response rate expressed by RECIST criteria, after two percutaneous liver perfusions with melphalan at a six week interval; •Number of curative resections after percutaneous perfusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety of percutaneous liver perfusions with the Delcath 2nd generation system; • Overall survival and overall progression free survival; • Duration of response and duration of stable disease; • Quality of life. | — |
Contacts
Public ContactE.M. de Leede
Outcome results
None listed