Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to investigate the clinical value of laparoscopic liver resection in the treatment of hepatocellular carcinoma by assessing its Surgical and oncologic outcomes comparing with open liver resection.

Official Title
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A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Laparoscopic liver resection
* Procedure: Open liver resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver solid tumor, with clinical diagnosis of hepatocellular carcinoma Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ The tumor location and size do not affect the dissection of hepatic hilar region Tumor size less than 10cm Without portal vein tumor thrombus Without intrahepatic or distant metastasis Willingness to participate in the study Able to understand the nature of the study and what will be required of them Body mass index of between 18 and 35 Child-Pugh classification of A to B American Society of Anesthesiologists (ASA) grading of I to III Exclusion Criteria: Pregnant or lactating women Unwillingness to participate Inability to give written informed consent Child-Pugh classification of C ASA grading of IV to V Tumor invasion of the inferior vena cava or confluence part of hepatic vein Decompensated liver cirrhosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic liver resection group<br> | Procedure: Laparoscopic liver resection<br>* participants will be performed with laparoscopic hepatectomy using laparoscopic instruments<br>* Other names: Laparoscopic hepatectomy;|
| Active Comparator: Open liver resection<br> | Procedure: Open liver resection<br>* participants will be performed with open hepatectomy using laparotomic instruments<br>* Other names: Open hepatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total survival time and disease free survival time |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical margins |  | 7 days | 
| Time to functional recovery |  | participants will be followed for the duration of hospital stay, an expected average of 6 days | 
| Postoperative hospital stay |  | participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Morbidity and mortality |  | up to 3 months | 
| Quality of life |  | up to 1 year | 
| Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor |  | participants will be followed for the duration of operation, an expected average of 90 min | 
| Regulatory T cells and associated cytokines in peripheral blood | Regulatory T cells and associated cytokines in peripheral blood will be tested 1day before operation,5 days, 3,6 months and 1,3,5 years after operation | up to 5 years | 
| Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma