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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT02799212
Eligibility Criteria:
Inclusion Criteria:
* Patients with HCC diagnosed by histology or by imaging findings according to the Barcelona Clinic Liver Cancer Group
* Patients with a single or multiple HCCs deemed to be resectable with a curative intent at the preoperative evaluation
* Patients for whom an indication for hepatectomy has been decided and approved by multidisciplinary board:
* by laparotomy
* by coelioscopy with resection of at least 2 liver segments
* Patients with any underlying liver disease with or without proven cirrhosis, regarding histological features (including F2-F3-F4 fibrosis with or without cirrhosis) or with other evidence of a diseased liver if no biopsy has been performed preoperatively (dysmorphic liver or evidence of portal hypertension at imaging findings, oesophageal varices at endoscopy)
* Age ≥ 18 years
* Patients with ability to understand and sign a written inform consent form
* Patients who will be available for follow-up
Exclusion Criteria:
* Patients participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (except interventional research with minimal risks and constraints that do not interfere with the judgement criteria of the study according to the judgement of the coordinating investigator).
* Patients with evidence of a healthy liver at biopsy
Disease-associated non-inclusion criteria include:
* Another histologic type of hepatic tumor besides HCC
* Distant extra-hepatic metastases, including peritoneal carcinomatosis
* The existence of complete portal thrombosis of the main portal trunk
Operative technique-associated non-inclusion criteria include:
\- Indication of coelioscopy with resection of less than 2 liver segments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02799212
Study Brief:
Protocol Section:
NCT02799212