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Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic liver resection
Open liver resection
Sponsored by
Sir Run Run Shaw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic liver resection group

Open liver resection

Arm Description

Outcomes

Primary Outcome Measures

Total survival time and disease free survival time

Secondary Outcome Measures

Surgical margins
Time to functional recovery
Postoperative hospital stay
Morbidity and mortality
Quality of life
Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor
Regulatory T cells and associated cytokines in peripheral blood
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
Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue

Full Information

First Posted
January 13, 2013
Last Updated
November 16, 2015
Sponsor
Sir Run Run Shaw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01768741
Brief Title
Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
Official Title
A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic liver resection group
Arm Type
Active Comparator
Arm Title
Open liver resection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic liver resection
Other Intervention Name(s)
Laparoscopic hepatectomy
Intervention Description
participants will be performed with laparoscopic hepatectomy using laparoscopic instruments
Intervention Type
Procedure
Intervention Name(s)
Open liver resection
Other Intervention Name(s)
Open hepatectomy
Intervention Description
participants will be performed with open hepatectomy using laparotomic instruments
Primary Outcome Measure Information:
Title
Total survival time and disease free survival time
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Surgical margins
Time Frame
7 days
Title
Time to functional recovery
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
Postoperative hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Morbidity and mortality
Time Frame
up to 3 months
Title
Quality of life
Time Frame
up to 1 year
Title
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
Title
Regulatory T cells and associated cytokines in peripheral blood
Description
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
Time Frame
up to 5 years
Title
Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Hospital costs
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiujun Cai, MD
Phone
0086-0571-86006605
Email
caixiujunzju@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiujun Cai, MD
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiujun Cai, MD
Phone
0086-0571-86006605
Email
caixiujunzju@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Renan Jin, MS
Phone
0086-0571-86006276
Email
jason198508@126.com

12. IPD Sharing Statement

Learn more about this trial

Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

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