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

The Influence of Radiofrequency-assisted Hepatectomy on the Perioperative Outcomes and the Long-term Prognosis of HCC With Cirrhosis：A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma; Cirrhosis
• Intervention / Treatment: Procedure: Radiofrequency-assisted Hepatectomy; Procedure: Conventional Hepatectomy

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Institute of Hepatobiliry surgery,Southwest Hospital
      • Contact: Rui Guo, Master of Medicine; Phone Number: 86-23-15922654727; Email: ruixx032@163.com
      • Principal Investigator: Xiaowu Li, MD-Ph D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: radiofrequency-assisted resection group（RF-R); Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.	Procedure: Radiofrequency-assisted Hepatectomy; Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.
Active Comparator: conventional liver resection group（CLR-R）; Conventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical.	Procedure: Conventional Hepatectomy; Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative liver injury	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.	postoperative 90 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood parameter change after operation	Blood parameter change after operation is measured by postoperative blood routine test till the hospitalization. The estimated average postoperative hospitalization ranges from 10 ot 15 days (generally 2 weeks). If the incidence of postoperative hepatic insufficiency occurred beyond hospitalization,blood routine test is also necessarily counted in.	discharge from hospital (2 weeks)

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Study Director: Xiaowu Li, MD-Ph D, Institute of Hepatobiliry surgery,Southwest Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: November 22, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: hepatectomy; radiofrequency-assisted（RF）; postoperative liver injury
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: SWHB2013-005