Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Southwest Hospital, China
Sponsor:
Information provided by (Responsible Party):
fengkai, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01713244
First received: October 21, 2012
Last updated: October 26, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • Recurrence-free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: fengkai, Institute of Hepatobiliary Surgery, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01713244     History of Changes
Other Study ID Numbers: SKLKF201209
Study First Received: October 21, 2012
Last Updated: October 26, 2012
Health Authority: China: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014