Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01713244
• Other study ID #: SKLKF201209
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2012
• Last updated: November 19, 2015
• Start date: October 2012
• Est. completion date: November 2016

Study information

• Verified date: November 2015
• Source: Southwest Hospital, China
• Contact: Kai Feng, M.D
• Phone: +86-23-13228683383
• Email: fengkai7688[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian countries. But the effectiveness of hepatectomy was depressed because of the high recurrence rate. The spreading of the cancer cell along the portal vein or the hepatic vein system during the operation account for the tumor recurrence. Using RFA to ablate and block the small vessels around the tumor before resection will reduce the spreading of the cancer cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone for the treatment of advanced HCC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• RFA assisted Hepatectomy
Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.
• Hepatectomy
Treat the advanced HCC with the hepatectomy only.

Locations

Country	Name	City	State
China	Institute of hepatobiliary surgery,Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events		2 years	No
Primary	Recurrence-free Survival		2 years	No
Secondary	Overall Survival		2 years	No