Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

Study Overview
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Brief Summary
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Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.

Conditions
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Hepatocellular Carcinoma, Laparoscopic Hepatectomy

Intervention / Treatment
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* Procedure: laparoscopic hepatectomy
* Procedure: open liver resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child-pugh A-B Primary hepatocellular carcinoma of the left liver lobe Tumor size ≤5cm in diameter KPS≥60 Exclusion Criteria: Significant abnormal liver function Significant abnormal Heart function Significant abnormal lung function Significant abnormal kidney function

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: laparoscopic hepatectomy<br>laparoscopic hepatectomy | Procedure: laparoscopic hepatectomy<br> <br> |
| Other: open liver resection<br>open liver resection | Procedure: open liver resection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of bleeding |  | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. | 
| time of operation |  | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. | 
| status of the resection margins |  | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. | 
| bile leakage |  | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. | 
| abdominal adhesion |  | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Participants will be followed for 5 years. | 
| disease-free survival |  | Participants will be followed for 5 years. | 
| time to disease recurrence |  | Participants will be followed for 5 years. |