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

Phase 1

• Conditions: Liver Cancer
• Interventions: Procedure: US-guided RFA

• Registration Number: NCT03026452
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2016-12
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RFA(radiofrequency ablation)	US-guided RFA	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.

Primary Outcome Measures

Name	Time	Method
Tumor size assessed by MRI	through study completion, an average of 2 year	Tumor size was estimated by MRI.

Secondary Outcome Measures

Name	Time	Method
Carcinoembryonic Antigen (CEA) level assessed by ELISA	through study completion, an average of 2 year	CEA level was assessed by enzyme linked immunosorbent assay (ELISA).
Alpha Fetoprotein (AFP) level assessed by ELISA	through study completion, an average of 2 year	AFP level was assessed by ELISA.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China