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Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

NCT ID: NCT01713244

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepatectomy

Using Hepatectomy for the treatment of advanced HCC

Group Type ACTIVE_COMPARATOR

Hepatectomy

Intervention Type PROCEDURE

Treat the advanced HCC with the hepatectomy only.

RFA assisted Hepatectomy

Ablating the liver tissue around the tumor before hepatectomy.

Group Type EXPERIMENTAL

RFA assisted Hepatectomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Hepatectomy

Treat the advanced HCC with the hepatectomy only.

Intervention Type PROCEDURE

Eligibility Criteria

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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. -

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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fengkai

Institute of Hepatobiliary Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuansheng Ma, Ph.D

Role: STUDY_DIRECTOR

Institute of hepatobiliary surgery,Southwest Hospital

Locations

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Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Feng, M.D

Role: CONTACT

[email protected]
+86-23-13228683383

Facility Contacts

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Kai Feng, M.D

Role: primary

[email protected]
+86-23-13228683383

Other Identifiers

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SKLKF201209

Identifier Type: -

Identifier Source: org_study_id