Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

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

A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

The purpose of this study is to investigate the clinical value of laparoscopic liver resection in the treatment of hepatocellular carcinoma by assessing its Surgical and oncologic outcomes comparing with open liver resection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • 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, 310000
        • Recruiting
        • Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
        • Contact:
        • Contact:

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Liver solid tumor, with clinical diagnosis of hepatocellular carcinoma
  • Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
  • The tumor location and size do not affect the dissection of hepatic hilar region
  • Tumor size less than 10cm
  • Without portal vein tumor thrombus
  • Without intrahepatic or distant metastasis
  • Willingness to participate in the study
  • Able to understand the nature of the study and what will be required of them
  • Body mass index of between 18 and 35
  • Child-Pugh classification of A to B
  • American Society of Anesthesiologists (ASA) grading of I to III

Exclusion Criteria:

  • Pregnant or lactating women
  • Unwillingness to participate
  • Inability to give written informed consent
  • Child-Pugh classification of C
  • ASA grading of IV to V
  • Tumor invasion of the inferior vena cava or confluence part of hepatic vein
  • Decompensated liver cirrhosis

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic liver resection group
Procedure: Laparoscopic liver resection
participants will be performed with laparoscopic hepatectomy using laparoscopic instruments
Other Names:
  • Laparoscopic hepatectomy
Active Comparator: Open liver resection
Procedure: Open liver resection
participants will be performed with open hepatectomy using laparotomic instruments
Other Names:
  • Open hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total survival time and disease free survival time
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical margins
Time Frame: 7 days
7 days
Time to functional recovery
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
participants will be followed for the duration of hospital stay, an expected average of 6 days
Postoperative hospital stay
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
Morbidity and mortality
Time Frame: up to 3 months
up to 3 months
Quality of life
Time Frame: up to 1 year
up to 1 year
Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor
Time Frame: participants will be followed for the duration of operation, an expected average of 90 min
participants will be followed for the duration of operation, an expected average of 90 min
Regulatory T cells and associated cytokines in peripheral blood
Time Frame: up to 5 years
Regulatory T cells and associated cytokines in peripheral blood will be tested 1day before operation,5 days, 3,6 months and 1,3,5 years after operation
up to 5 years
Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue
Time Frame: 7 days
7 days

Other Outcome Measures

Outcome Measure
Time Frame
Hospital costs
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 9 days
participants will be followed for the duration of hospital stay, an expected average of 9 days

Collaborators and Investigators

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

Sponsor

Sir Run Run Shaw Hospital

Investigators

  • Principal Investigator: XiuJun Cai, MD, 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

December 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 13, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRRSH20121225-2

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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