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Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

RFA assisted Hepatectomy

Hepatectomy

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Radiofrequency Ablation, Hepatectomy, Recurrence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of HCC confirmed at our hospital.
Intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no more than 8cm.
Liver function of Child-Pugh Class A or B.
Tumors lacked intrahepatic and extrahepatic metastasis.
Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
Indocyanine green retention at 15 minutes (ICG-15) of <10%.
No evidence of coagulopathy: platelet count > 50 × 109/L and a prolonged prothrombin time of < 5 seconds.
No other anti-tumor therapy received before the treatment. -

Exclusion Criteria:

Patients met the inclusion criteria but declined to participate.
Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.

Sites / Locations

Institute of hepatobiliary surgery,Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hepatectomy

RFA assisted Hepatectomy

Arm Description

Using Hepatectomy for the treatment of advanced HCC

Ablating the liver tissue around the tumor before hepatectomy.

Outcomes

Primary Outcome Measures

Recurrence-free Survival

Secondary Outcome Measures

Overall Survival

Full Information

NCT ID

NCT01713244

First Posted

October 21, 2012

Last Updated

November 19, 2015

Sponsor

Southwest Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT01713244

Brief Title

Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southwest Hospital, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Radiofrequency Ablation, Hepatectomy, Recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hepatectomy

Arm Type

Active Comparator

Arm Description

Using Hepatectomy for the treatment of advanced HCC

Arm Title

RFA assisted Hepatectomy

Arm Type

Experimental

Arm Description

Ablating the liver tissue around the tumor before hepatectomy.

Intervention Type

Procedure

Intervention Name(s)

RFA assisted Hepatectomy

Intervention Description

Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.

Intervention Type

Procedure

Intervention Name(s)

Hepatectomy

Intervention Description

Treat the advanced HCC with the hepatectomy only.

Primary Outcome Measure Information:

Title

Recurrence-free Survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Survival

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

Number of participants with adverse events

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of HCC confirmed at our hospital. Intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no more than 8cm. Liver function of Child-Pugh Class A or B. Tumors lacked intrahepatic and extrahepatic metastasis. Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches. Indocyanine green retention at 15 minutes (ICG-15) of <10%. No evidence of coagulopathy: platelet count > 50 × 109/L and a prolonged prothrombin time of < 5 seconds. No other anti-tumor therapy received before the treatment. - Exclusion Criteria: Patients met the inclusion criteria but declined to participate. Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites. Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kai Feng, M.D

Phone

+86-23-13228683383

fengkai7688@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kuansheng Ma, Ph.D

Organizational Affiliation

Institute of hepatobiliary surgery,Southwest Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Institute of hepatobiliary surgery,Southwest Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400038

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kai Feng, M.D

Phone

+86-23-13228683383

fengkai7688@hotmail.com

First Name & Middle Initial & Last Name & Degree

Kai Feng, M.D

12. IPD Sharing Statement

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Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

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