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Ethanol Ablation Using a Multi-pronged Needle and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma: a Randomized Clinical Trial


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Ethanol Ablation Using a Multi-pronged Needle and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma: a Randomized Clinical Trial


Patients with early-stage (single tumor no more than 5 cm or up to 3 tumors each no more
than 3 cm in size) primary hepatocellular carcinoma will be randomized into two percutaneous
ablation treatment arms, including radiofrequency ablation and multi-pronged ethanol
ablation. The local treatment responses, complications,and long-term disease-free survivals
and overall survivals are analyzed.


Inclusion Criteria:



- Primary hepatocellular carcinoma, single tumor ≤5 cm or up to 3 tumors each ≤3 cm

- Ultrasound detectable tumor

- Liver function classified as Child-Pugh A or B

- Platelet count > 50,000/mm3, or prothrombin activity > 50%

- Not suitable for resection or patient refused surgery

Exclusion Criteria:

- Vascular invasion and extrahepatic spread

- Patients allergic to ethanol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Local treatment responses

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Mingde Lu, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ministry of Health

Study ID:

EARFArct

NCT ID:

NCT00844454

Start Date:

May 2008

Completion Date:

May 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • PEI
  • RF ablation
  • tumor ablation
  • Carcinoma
  • Carcinoma, Hepatocellular

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