Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma

January 8, 2014 updated by: Yunfei Yuan, Sun Yat-sen University

Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma ----A Prospective Randomized Controlled Clinical Trail

The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph node for those patients. Recently, more and more studies had found the incidence of lymph node metastasis was higher in autopsy specimen than those in operable patients.

This project is a prospective randomized controlled trial, planning to compare hepatectomy with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC patients, to reach a further understanding of the role of lymphadenectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • age 18 to 65 years;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
  • good liver function with Pugh-Child Class A or B;
  • indocyanine green retention at 15 minutes (ICG-R15) <15%;
  • without severe cirrhosis;
  • the diameter of tumor is equal to or more than 3 cm;
  • the liver resection could be assessed R0 (the define of R0 resection will be explained in the section of Surgical procedures);
  • absence of extrahepatic metastasis.

Exclusion Criteria:

  • the diameter of tumor is less than 3 cm;
  • palliative resection of tumor;
  • with the history of hepatic encephalopathy, ascites, and variceal bleeding;
  • with severe hepatic cirrhosis;
  • tumor rupture;
  • with the history of upper abdominal surgery, it is tough to remove the regional lymph nodes; or it is unable to be resected when multiple lymph nodes mixed and fixed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hepatectomy combined lymphadenectomy
Procedure: hepatectomy combined with lymphadenectomy
Active Comparator: hepatectomy
hepatectomy alone
Procedure: hepatectomy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 5 year
The recurrence-free survival time was defined as the time from the date of resection or ablation to the time of recurrence, metastasis or last follow-up.
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operation complication
Time Frame: 90-d after surgery
90-d after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yunfei Yuan, MD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 4, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rvrl2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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