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Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by fengkai, Southwest Hospital, China.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01713244
First Posted: October 24, 2012
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
fengkai, Southwest Hospital, China
  Purpose
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.

Condition Intervention
Hepatocellular Carcinoma Procedure: RFA assisted Hepatectomy Procedure: Hepatectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma

Further study details as provided by fengkai, Southwest Hospital, China:

Primary Outcome Measures:
  • Recurrence-free Survival [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ]

Other Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 2 years ]

Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hepatectomy
Using Hepatectomy for the treatment of advanced HCC
Procedure: Hepatectomy
Treat the advanced HCC with the hepatectomy only.
Experimental: RFA assisted Hepatectomy
Ablating the liver tissue around the tumor before hepatectomy.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713244


Contacts
Contact: Kai Feng, M.D +86-23-13228683383 fengkai7688@hotmail.com

Locations
China, Chongqing
Institute of hepatobiliary surgery,Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Kai Feng, M.D    +86-23-13228683383    fengkai7688@hotmail.com   
Principal Investigator: Kai Feng, M.D         
Sponsors and Collaborators
Southwest Hospital, China
Investigators
Study Director: Kuansheng Ma, Ph.D Institute of hepatobiliary surgery,Southwest Hospital
  More Information

Responsible Party: fengkai, Institute of Hepatobiliary Surgery, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01713244     History of Changes
Other Study ID Numbers: SKLKF201209
First Submitted: October 21, 2012
First Posted: October 24, 2012
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by fengkai, Southwest Hospital, China:
Hepatocellular Carcinoma
Radiofrequency Ablation
Hepatectomy
Recurrence

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases