Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

November 16, 2015 updated by: Xiujun Cai, Sir Run Run Shaw Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma C-reactive protein (CRP) level
Time Frame: up to 7 days
CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum
Time Frame: up to 7 days
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
Time Frame: up to 7 days
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
Time Frame: up to 7 days
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
Time Frame: up to 7 days
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
Time Frame: up to 7 days
up to 7 days
Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression
Time Frame: 24 hours
24 hours
Time to functional recovery
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Postoperative hospital stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Participants will be followed for the duration of hospital stay, an expected average of 8 days
Morbidity and mortality
Time Frame: up to 1 month
up to 1 month
Quality of life
Time Frame: up to 1 month
up to 1 month
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
participants will be followed for the duration of operation, an expected average of 120 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Hospital costs
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Run Run Shaw Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SRRSH20121225-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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