Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis
Conditions
Hepatocellular Carcinoma - Cirrhosis
Conditions: official terms
Carcinoma, Hepatocellular - Liver Cirrhosis
Conditions: Keywords
radiofrequency-assisted(RF), hepatectomy, postoperative liver injury
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Radiofrequency-assisted Hepatectomy Type: Procedure
Name: Conventional Hepatectomy Type: Procedure
Overall Status
Recruiting
Summary
Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted(RFA)hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas(HCC),but its influence on the prognosis of HCC patients,especially for those with cirrhosis,is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Aged from 18 to 65 years , no gender restriction.

- Clinical diagnosis of resectable HCC.

- Preoperative liver function test showed Child-Pugh Class A or B.

- Indocyanine green retention at 15 minutes (ICG-15) of <30%.

- Acceptable clotting profile :platelet count > 50 x 109/L and a prolonged prothrombin time of < 5 seconds.

- Enough relative residual liver volume (%RLV) ≥ 40%.

- No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.

- No other anti-tumor therapy received before the treatment.

- No metastasis in lymphnode or other organs.

- Written consent inform assigned.

Exclusion Criteria:

- Pregnancy.

- Intraoperative findings of tumor rupture,extrahepatic tumor or lymphnode metastasis.

- Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
Location
Institute of Hepatobiliry surgery,Southwest Hospital
Chongqing, Chongqing, China
Status: Recruiting
Contact: Rui Guo, Master of Medicine - 86-23-15922654727 - ruixx032@163.com
Start Date
November 2013
Completion Date
November 2018
Sponsors
Southwest Hospital, China
Source
Southwest Hospital, China
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page