Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma

NCT ID: NCT02031952

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

hepatectomy combined lymphadenectomy

hepatectomy combined lymphadenectomy

Group Type: EXPERIMENTAL

hepatectomy combined with lymphadenectomy

Intervention Type: PROCEDURE

hepatectomy

hepatectomy alone

Group Type: ACTIVE_COMPARATOR

hepatectomy alone

Intervention Type: PROCEDURE

Interventions

hepatectomy combined with lymphadenectomy

Intervention Type: PROCEDURE

hepatectomy alone

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yunfei Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunfei Yuan, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

Rvrl2005

Identifier Type: -

Identifier Source: org_study_id