Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.

Detailed Description
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Liver resection is the most important treatment of hepatocellular carcinoma (HCC). Open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. Laparoscopic hepatectomy was widely used since it was reported by Reich in 1991. With the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. The Louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter < 5cm, located in segment II-VI. Previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. The mortality, mobility, the overall survival and the disease-free survival was same in these two groups. So far, however, the curative effect and safety research of laparoscopic versus open liver resection for HCC is limited to retrospective study and case-control study. A prospective, randomized, controlled study is urgently needed. This study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for HCC.

Official Title
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A Prospective Randomized Control Trail of Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: laparoscopic hepatectomy
* Procedure: Open hepatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis was HCC The tumor was located in segment: II, III, IVb, V, VI The tumor diameter < 5cm Without thrombosis in the portal vein, hepatic vein or bile duct Without intrahepatic and systemic metastasis The Child-pugh score was A-B7 The ASA（American Society of Anesthesiologists） score was I-III The patient age was between 18-75 Sign the informed consent, and can fully understand the research content Exclusion Criteria: Have surgery contraindications Pregnant or lactating women The Child-pugh score was B8-C The ASA（American Society of Anesthesiologists） score was IV-V With other malignant tumor With mental illness Participated in other clinical trials in the last three months Underwent other treatments(chemotherapy or radiotherapy) before operation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic hepatectomy<br>The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery | Procedure: laparoscopic hepatectomy<br>* The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy<br>|
| Experimental: Open hepatectomy<br>The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery | Procedure: Open hepatectomy<br>* The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The overall survival of HCC patients after operation | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | The disease free survival of HCC patients after operation | 5 years | 
| Incidence of postoperative complications | Incidence of postoperative complications | 1 month |