Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031952
• Other study ID #: Rvrl2005
• Status: Completed
• Phase: N/A
• First received: January 4, 2014
• Last updated: January 8, 2014
• Start date: December 2005
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• hepatectomy combined with lymphadenectomy

• hepatectomy alone

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	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	Yes
Secondary	Post-operation complication		90-d after surgery	Yes