Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

Study Overview
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Brief Summary
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The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.

Official Title
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A Randomized Controlled Trial of Acute Surgical Trauma and Stress Response of Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

Conditions
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Benign Lesions in Left Liver

Intervention / Treatment
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* Procedure: Laparoscopic left hemihepatectomy
* Procedure: Open left hemihepatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with benign lesions who requires left hemihepatectomy Child-Pugh classification of A to B American Society Of Anesthesiologists (ASA) grading of I to III a body mass index of between 18 and 35 willingness to participate in the study able to understand the nature of the study and what will be required of them Exclusion Criteria: pregnant or lactating women unwillingness to participate Child-Pugh classification of C ASA grading of IV to V with condition of acute inflammatory,fever or diabetes mellitus with autoimmune disease or immunodeficiency taking drugs that affect the immune system

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic left hemihepatectomy group<br>Group of patients that are operated with laparoscopic left hemihepatectomy | Procedure: Laparoscopic left hemihepatectomy<br>* participants will be performed with laparoscopic left hepatectomy using laparoscopic instruments<br>* Other names: Laparoscopic left hepatectomy;|
| Active Comparator: Open left hemihepatectomy<br>Group of patients operated with open left hemihepatectomy | Procedure: Open left hemihepatectomy<br>* participants will be performed with traditional open left hepatectomy using laparotomic instruments<br>* Other names: Open left hepatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma C-reactive protein (CRP) level | CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum | interleukin-6 and interleukin-10 will be tested before operation, 3,12,24 hours and 3,5,7 days after operation | up to 7 days | 
| Oxidative stress status including plasma malondialdehyde level and total antioxidant capacity | plasma malondialdehyde level and total antioxidant capacity will be tested before operation, 3,12,24 hours and 3,5,7 days after operation | up to 7 days | 
| Immune status including white blood cell count and human leukocyte antigen DR (HLA-DR) expression | white blood cell count and human leukocyte antigen DR (HLA-DR) expression will be tested before operation, 3,12,24 hours and 3,5,7 days after operation | up to 7 days | 
| Status of insulin resistant | Status of insulin resistant will be tested before operation, 3,12,24 hours and 3,5,7 days after operation | up to 7 days | 
| Systemic inflammatory response syndrome |  | up to 7 days | 
| Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression |  | 24 hours | 
| Time to functional recovery |  | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Postoperative hospital stay |  | Participants will be followed for the duration of hospital stay, an expected average of 8 days | 
| Morbidity and mortality |  | up to 1 month | 
| Quality of life |  | up to 1 month | 
| Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion |  | participants will be followed for the duration of operation, an expected average of 120 minutes |