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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT01486134
Eligibility Criteria:
Inclusion Criteria:
* Patient of 18 year old.
* Up to 3 tumors unresectable suspected to be HCC according the criteria as previously defined by EASL and recently revised by AASLD among them at least one having a maximal diameter equal or larger than 5 cm.
* Proof of underlying cirrhosis.
* Multidisciplinary decision of RF ablation treatment
* Informed consent of patient
* Available healthcare insurance
Exclusion Criteria:
* Patient with short term life training uncontrollable disease
* Pregnancy
* Follow up Impossible
* Contra indication for general anesthesia
* Contra indication for MR examination with gadolinium injection
* Tumor located at less than 10 mm from colonic wall or main biliary tract
* Tumor invisible on MR examination
* Absence of safe percutaneous course to puncture the tumor
* Child - Pugh B or C cirrhosis
* Abundant ascites
* PROTHROMBIN activity \< 50 %
* Platelet count \< 40 .10 3/ml
* Antecedent of ascitis decompensation
* Severe portal hypertension defined by the presence of large oesophageal variceal (grade 2) , of radiological ascitis or umbilical vein repermeabilisation
* Elevation of transaminases (\>3 upper limit normal range)
* Antecedent of biliodigestive anastomosis
* Antecedent of endoscopic sphincterotomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01486134
Study Brief:
Protocol Section:
NCT01486134