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A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma


N/A
18 Years
70 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma


Inclusion Criteria:



1. Diagnosis of HCC confirmed at our hospital.

2. Intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no
more than 8cm.

3. Liver function of Child-Pugh Class A or B.

4. Tumors lacked intrahepatic and extrahepatic metastasis.

5. Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary
branches.

6. Indocyanine green retention at 15 minutes (ICG-15) of <10%.

7. No evidence of coagulopathy: platelet count > 50 × 109/L and a prolonged prothrombin
time of < 5 seconds.

8. No other anti-tumor therapy received before the treatment. -

Exclusion Criteria:

1. Patients met the inclusion criteria but declined to participate.

2. Patients with severe portal hypertension, a history of esophageal variceal
hemorrhage, severe hypersplenism syndrome, or refractory ascites.

3. Patients whose permanent pathology after treatment suggested metastatic liver cancer
or primary liver cancer of another tissue type.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence-free Survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Kuansheng Ma, Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

Institute of hepatobiliary surgery,Southwest Hospital

Authority:

China: Ethics Committee

Study ID:

SKLKF201209

NCT ID:

NCT01713244

Start Date:

October 2012

Completion Date:

November 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Radiofrequency Ablation
  • Hepatectomy
  • Recurrence
  • Carcinoma
  • Carcinoma, Hepatocellular

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