Effectivity and Safety of Ultrasound-guided Percutaneously Radiofrequency Ablation for Liver Cancer

Zhejiang University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Cancer

Treatments: Procedure: US-guided RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT03026452

RFA-001

Details and patient eligibility

About

To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation for liver tumors, the investigators used preoperative and postoperative US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Patients with Child-Pugh A/B, Patients with PLT(platelet count) ≥ 50*10e9/L and PT(prothrombin time) ≤ 20s.

Exclusion criteria

• Patients with blood coagulation dysfunction, ChildPugh score≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

RFA(radiofrequency ablation)

Experimental group

Description:

The investigators used percutaneously US-guided RFA(radiofrequency ablation) for small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.

Treatment:

Procedure: US-guided RFA