Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma

NCT02031952 | Completed DMC

• 1 other identifier: Rvrl2005
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Keywords

hepatocellular carcinoma; hepatectomy; lymphadenectomy; complication; prognosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Post-operation complication

  90-d after surgery

Study Arms (2)

hepatectomy combined lymphadenectomy

EXPERIMENTAL

hepatectomy combined lymphadenectomy

Procedure: hepatectomy combined with lymphadenectomy

hepatectomy

ACTIVE COMPARATOR

hepatectomy alone

Procedure: hepatectomy alone

Interventions

hepatectomy combined with lymphadenectomy PROCEDURE

hepatectomy combined lymphadenectomy

hepatectomy alone PROCEDURE

hepatectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Lymph Node Excision; Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Yunfei Yuan, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2014
• First Posted: January 9, 2014
• Study Start: December 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2013
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

CN (1)