Colorectal liver metastases synonyme: metastases in the liver derived from colorectal carcinoma
Conditions
Interventions
Guideline indication for resectability of colorectal liver metastasis will be
judged in consensus by a multidisciplinary liver team. After study inclusion,
all patients will undergo a laparotomy acc
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Screening must be performed no longer than 4 weeks prior to study inclusion. Subjects are eligible if they meet the following criteria: * Histological or cytological documentation of primary colorectal tumor * Liver metastases visible on FDG PET-CT or contrast-enhanced CT, size * 3,5 cm. * Resectability (re)confirmed by intraoperative US * Age 18 years or older * WHO performance status 0 * 2 * Life expectancy of at least 12 weeks * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion: Hemoglobin * 5.6 mmol/L; Absolute neutrophil count (ANC) * 1,500/mm3; Platelet count * 100*109/l; Total bilirubin * 1.5 times the upper limit of normal (ULN); ALT and AST * 2.5 x ULN; Serum creatinine * 1.5 x ULN or a calculated creatinine clearance ³ 50 ml/min; Prothrombin time or INR
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria at the time of screening will be excluded: * Lesion > 3,5 cm * History of cardiac disease: - Congestive heart failure >NYHA class 2; - Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening); - Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted) * History of epilepsy * Uncontrolled hypertension. Blood pressure must be *160/95 mmHg at the time of screening without medication or on a stable antihypertensive regimen. * Uncontrolled infections (> grade 2 NCI-CTC version 3.0). * Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. * Immunotherapy * 6 weeks prior to the procedure * Chemotherapy within 12 weeks before surgery * Radiotherapy, RFA or MWT treatment of target lesions prior to resection * Concomitant use of dexamethasone, anti-convulsants and anti-arrhythmic drugs. * Severe allergy for contrast media not controlled with premedication. * Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the safety of the IRE procedure using the NanoKnife. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are feasibility (including procedure time), size and shape of ablated area and the extent of cellular damage and apoptosis. | — |
Countries
Netherlands
Outcome results
None listed