Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT01008657
Eligibility Criteria:
Inclusion Criteria:
* Adults \> 18 years old, holder of up to 3 nodules less than 4 cm in diameter
* Diagnosis of hepatocellular carcinoma according to American Society of Liver Study non invasive criteria or based on histological proof
* Non invasive diagnosis of cirrhosis according to French Haute Authority of illness guideline or based on histological proof
* No previous treatment for hepatocellular carcinoma
* Multidisciplinary decision of treatment by radiofrequency ablation
Exclusion Criteria:
* Adult patient under guardianship or trusteeship, homeless
* Patient with potentially short term life-threatening serious co-infection (apart from viral B or C, or VIH co-infection)
* Pregnant or breastfeeding woman
* Patient for whom regular follow-up is impossible whatever the cause
* Contra indication to general anaesthesia
* Technical impossibility to perform the procedure under ultrasound guidance
* Boundary of the tumor located at less than 1 cm distance from colonic wall or main biliary tract (main right or left bill ducts and common bill duct)
* Tumor invisible with ultrasound
* Lack of safe percutaneous course which can be planned
* Tumor in which more than four biopsies pass were previously performed (cumulated during one or several previous biopsies sessions)
* Contra indication to perform CT or MRI with contrast medium (GADOLINITE or iodinate) intravenous injection
* Child-Pugh B or C cirrhosis (apart from the transitory liver failures in the setting of acute hepatitis related to alcohol abuse)
* Total detachment of the anterior face of the liver from internal abdominal wall due to abundant ascites.
* Prothrombin activity \< 50 %
* Platelet count \<40 .10 3/ml
* Platelet dysfunction or congenital impaired blood coagulating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01008657
Study Brief:
Protocol Section:
NCT01008657