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

First Affiliated Hospital of Zhejiang University1 site in 1 country400 target enrollmentJanuary 2013

ConditionsLiver Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Liver Cancer
Sponsor: First Affiliated Hospital of Zhejiang University
Enrollment: 400
Locations: 1
Primary Endpoint: Tumor size assessed by MRI
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

December 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

First Affiliated Hospital of Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Tumor size assessed by MRI

Time Frame: through study completion, an average of 2 year

Tumor size was estimated by MRI.

Secondary Outcomes

Carcinoembryonic Antigen (CEA) level assessed by ELISA(through study completion, an average of 2 year)
Alpha Fetoprotein (AFP) level assessed by ELISA(through study completion, an average of 2 year)