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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT05990257
Eligibility Criteria:
Inclusion Criteria:
Primary hepatic carcinoma was considered if characterized by a solitary tumor (≤5cm in maximum diameter) or by the presence of multiple tumors (2-3 in number, each ≤3cm in maximum diameter). Importantly, these tumors were required to be devoid of vascular invasion, biliary intrusion, contiguous organ invasion, or any evidence of distant metastasis.
Another group included in the study were patients with hepatic metastases, limited to no more than 5 tumors each measuring ≤3cm in maximum diameter.
Furthermore, patients with hepatic hemangioma were also considered for inclusion. Specific criteria applied in these cases included tumors larger than 5cm in maximum diameter that showed considerable growth (imaging findings suggest that the diameter of the tumor has increased by more than 1cm) in the preceding two years and were associated with persistent hemangioma-related abdominal pain or discomfort. Alternatively, tumors measuring up to 5cm in maximum diameter, exhibiting a pronounced growth propensity and located at the first, second, or third hilar region in close proximity to the hilar bile duct, portal vein, hepatic artery, hepatic vein, or inferior vena cava were also considered. And all these patients cannot tolerate surgery due to other organ damage or do not want to undergo surgical treatment.
The ASA grade is II or III.
Exclusion Criteria:
Patients with severe underlying medical conditions that could potentially prevent them from tolerating the US-guided MWA procedure were ruled out.
Those with tumors invading blood vessels, bile ducts, adjacent organs, or presenting with extrahepatic metastasis were also excluded.
Further, any cases presenting with uncorrectable coagulation disorders, thrombocytopenia, or currently under administration of anticoagulant agents were deemed unfit for the study.
Finally, patients were excluded if a safe trajectory for executing US-guided MWA was not feasible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05990257
Study Brief:
Protocol Section:
NCT05990257