Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Me… (NCT01799044) | Clinical Trial Compass
CompletedPhase 1
Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases
Netherlands10 participantsStarted 2012-11
Plain-language summary
Irreversible electroporation is a new, minimal-invasive image-guided treatment to treat tumors near or around vulnerable structures, such as central liver tumors.
To investigate the safety and efficacy of IRE in the treatment of colorectal liver metastases, patients with resectable colorectal liver metastases undergo IRE and resection of the metastases in the same session. After resection, the specimen is examined macroscopically to determine vitality using a specific vitality staining (triphenyl-tetrazoliumchloride) and to visualize the exact ablation zone. Subsequently, histopathologic examination is used to determine type of cell death and the microscopic ablation zone.
The investigators hypothesize that IRE is a safe effective method to treat colorectal liver metastasis and that cell damage and cell death is demonstrated as soon as 1 hour after the procedure.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological or cytological documentation of primary colorectal tumor
* Liver metastases visible on FDG PET-CT or ceCT, size ≤ 3,5 cm and eligible for resection
* Resectability re-confirmed per-operatively by US
* Age \> 18 years
* 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 \< 1.5 x ULN;
* Activated partial thromboplastin time \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician).
* Written informed consent.
Exclusion Criteria:
* Lesion \> 3,5 cm size
* History of epilepsy
* 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).
* Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen.…
What they're measuring
1
Safety
Timeframe: participants will be followed for the duration of hospital stay, an expected average of 1 week