Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis

Not Applicable

• Conditions: Hepatocellular Carcinoma; Cirrhosis

• Registration Number: NCT01992978
• Lead Sponsor: Southwest Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-25
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-22
• Last Update Posted: 2015-11-24
• Primary Completion: 2017-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative liver injury	postoperative 90 days	The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	postoperative 90 days	It is evaluated according to the the Clavien-Dindo Classification of surgical complications. Postoperative mortality and morbidity are measured.
Overall survival	1,3,5-year overall survival

Trial Locations

Locations (1)

Institute of Hepatobiliry surgery,Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China