Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

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

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

Study Overview

• Status: Completed
• Conditions: Benign Lesions in Left Liver
• Intervention / Treatment: Procedure: Laparoscopic left hemihepatectomy; Procedure: Open left hemihepatectomy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Laparoscopic left hemihepatectomy group; Group of patients that are operated with laparoscopic left hemihepatectomy	Procedure: Laparoscopic left hemihepatectomy; participants will be performed with laparoscopic left hepatectomy using laparoscopic instruments; Other Names: Laparoscopic left hepatectomy
ACTIVE_COMPARATOR: Open left hemihepatectomy; Group of patients operated with open left hemihepatectomy	Procedure: Open left hemihepatectomy; participants will be performed with traditional open left hepatectomy using laparotomic instruments; Other Names: Open left hepatectomy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Hospital costs	Participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 13, 2013
• First Posted (ESTIMATE): January 15, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: SRRSH20121225-1