Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma

Study Overview
=================
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.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: hepatectomy combined with lymphadenectomy
* Procedure: hepatectomy alone


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hepatectomy combined lymphadenectomy<br>hepatectomy combined lymphadenectomy | Procedure: hepatectomy combined with lymphadenectomy<br> <br> |
| Active Comparator: hepatectomy<br>hepatectomy alone | Procedure: hepatectomy alone<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, hepatectomy, lymphadenectomy, complication, prognosis