Hepatocellular carcinoma and liver metastases between 1.5 - 4 cm of diameter Cancer
Conditions
Interventions
Current interventions as of 15/06/2020:
Radio-frequency ablation with a "Cool-wet" radio-frequency system
Phase II: Randomized, parallel-group single-blind study
1. Group MWA: Conventional hepatic abl
Sponsors
Parc de Salut Mar- Hospital del Mar
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Nodules suggestive of HCC or liver metastases from any source as abdominal CT, MRI or biopsy. The initial imaging test (CT or MRI) must not be older than 30 days (50 days maximum tolerance). 2. Considered unresectable hepatic nodules in multidisciplinary and capable local treatment session 3. Number of nodes: between 1 and 3 4. Size of the nodules: between 1.5 and 4 cm 5. Percutaneous, laparoscopic or open surgical access. 6. Signature of informed consent 7. Aged at least 18
Exclusion criteria
Exclusion criteria: 1. Higher than third level of Anesthetic risk measured by the classification of the American Association anesthesia (ASA IV) 2. Carrier of a cardiac pacemaker 3. Thrombocytopenia <50,000 / mL 4. Suspicion of thrombosis portal by presence of tumor 5. Child C and grading of hepatic failure 6. Previous biliodigestive anatomosis 7. Hepatic subcapsular nodule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/06/2020: 1. Technical success evaluated as a complete tumor coverage by the ablation zone at 1-month follow-up 2. Local tumour progression after 2 years of follow-up, measured as complete tumor coverage by the ablation zone and the appearance of any tumor focus in contact with ablation zone after 2-years follow-up Previous primary outcome measures: 1. HLR (Hepatic local recurrence): Characterized by a partial response (PR) or disease progression (DP) of the treated target lesion according to RECIST 1.1 VA. in the abdominal CT or MRI at 6 months (maximum tolerance 50 days) and then every 6 months until 5 years. The maximum cutting thickness to evaluated this is 5 mm 2. MDA (Minimum Diameter Ablation): Defined as the smallest diameter of a single ablation measured by an abdominal CT or MRI at 6-months of the procedure. When they have been treated more than one target lesion, the smallest diameter will be considered | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/06/2020: 1. Safety: all treatment-related complications classified according to the Society of Interventional Radiology guidelines by treated tumor basis taking into account the highest grade. Complications recorded during the total follow-up of the patients. 2. Overall survival (OS) measured as the mean survival expressed in months per each group of treatment 3. Short to long diameter ratio (SLR) of the ablation measured from the TAC performed 1 month after the ablation 4. Sphericity ratio (SR) measured as the largest diameter to average of the two remaining diameters of the ablation zone. Ratio close to 1 implies more spherical shape, measured from the TAC performed 1 month after the ablation. 5. Surface area of the coagulation zone measured in cm² from the reconstruction of the coagulation zone (1 month after the ablation) 6. Coefficient of variation (CV) as a measure for reproducibility expressed in % and measured from the reconstruction of the coagulation zone (1 month after the ablation) Previous secondary outcome measures: 1. Maximum diameter of the ablation (anteroposterior, transverse and craniocaudal) 2. Mean volume of the ablation, measured by digital reconstruction from CT or MRI after a month of PO using appropriate image software | — |
Countries
Spain
Contacts
Public ContactRita Quesada
Outcome results
None listed