Treatment of primary and secondary liver tumors with an hepatic ablation cool-wet radiofrequency system.

Not Applicable

Completed

• Conditions: Hepatocellular carcinoma and liver metastases between 1.5 - 4 cm of diameter; Cancer

• Registration Number: ISRCTN73194360
• Lead Sponsor: Parc de Salut Mar- Hospital del Mar

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35013377/ (added 10/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-14
• Study Completion: 2020-06-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 15/06/2020:<br>1. Technical success evaluated as a complete tumor coverage by the ablation zone at 1-month follow-up<br>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<br><br>Previous primary outcome measures:<br>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<br>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