Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02031952

Enrollment

Registered

2014-01-09

Start date

2005-12-31

Completion date

2013-06-30

Last updated

2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, hepatectomy, lymphadenectomy, complication, prognosis

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.

Interventions

PROCEDUREhepatectomy combined with lymphadenectomy

PROCEDUREhepatectomy alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Recurrence-free survival	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.

Secondary

Measure	Time frame
Post-operation complication	90-d after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026