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Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

This study is currently recruiting participants.
Verified January 2013 by Sir Run Run Shaw Hospital
Sponsor:
Information provided by (Responsible Party):
Xiujun Cai, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier:
NCT01768728
First received: January 9, 2013
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Benign Lesions in Left Liver
 Procedure: Laparoscopic left hemihepatectomy
Procedure: Open left hemihepatectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Acute Surgical Trauma and Stress Response of Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sir Run Run Shaw Hospital:

Primary Outcome Measures:
  • Plasma C-reactive protein (CRP) level [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation


Secondary Outcome Measures:
  • Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    interleukin-6 and interleukin-10 will be tested before operation, 3,12,24 hours and 3,5,7 days after operation

  • Oxidative stress status including plasma malondialdehyde level and total antioxidant capacity [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    plasma malondialdehyde level and total antioxidant capacity will be tested before operation, 3,12,24 hours and 3,5,7 days after operation

  • Immune status including white blood cell count and human leukocyte antigen DR (HLA-DR) expression [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    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

  • Status of insulin resistant [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    Status of insulin resistant will be tested before operation, 3,12,24 hours and 3,5,7 days after operation

  • Systemic inflammatory response syndrome [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time to functional recovery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
  • Postoperative hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days ] [ Designated as safety issue: No ]
  • Morbidity and mortality [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion [ Time Frame: participants will be followed for the duration of operation, an expected average of 120 minutes ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Hospital costs [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Open left hepatectomy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768728

Contacts
Contact: Xiujun Cai, MD 0086-0571-86006605 caixiujunzju@yahoo.com.cn

Locations
China, Zhejiang
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Xiujun Cai, MD     0086-0571-86006605     caixiujunzju@yahoo.com.cn    
Contact: Renan Jin, MS     0086-0571-86006276     jason198508@126.com    
Principal Investigator: Xiujun Cai, MD            
Sponsors and Collaborators
Sir Run Run Shaw Hospital
  More Information

No publications provided

Responsible Party: Xiujun Cai, Executive Vice-President, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT01768728     History of Changes
Other Study ID Numbers: SRRSH20121225-1
Study First Received: January 9, 2013
Last Updated: January 14, 2013
Health Authority: China: Ministry of Health

ClinicalTrials.gov processed this record on May 22, 2013