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Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

Primary Purpose

Laparoscopic Hepatectomy, Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic hepatectomy
open liver resection
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Hepatectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Child-pugh A-B
  • Primary hepatocellular carcinoma of the left liver lobe
  • Tumor size ≤5cm in diameter
  • KPS≥60

Exclusion Criteria:

  • Significant abnormal liver function
  • Significant abnormal Heart function
  • Significant abnormal lung function
  • Significant abnormal kidney function

Sites / Locations

  • Sun Yat-sen Memorial Hospital,Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

laparoscopic hepatectomy

open liver resection

Arm Description

laparoscopic hepatectomy

open liver resection

Outcomes

Primary Outcome Measures

amount of bleeding
time of operation
status of the resection margins
bile leakage
abdominal adhesion

Secondary Outcome Measures

overall survival
disease-free survival
time to disease recurrence

Full Information

First Posted
April 29, 2014
Last Updated
May 2, 2014
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02131441
Brief Title
Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Hepatectomy, Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic hepatectomy
Arm Type
Other
Arm Description
laparoscopic hepatectomy
Arm Title
open liver resection
Arm Type
Other
Arm Description
open liver resection
Intervention Type
Procedure
Intervention Name(s)
laparoscopic hepatectomy
Intervention Type
Procedure
Intervention Name(s)
open liver resection
Primary Outcome Measure Information:
Title
amount of bleeding
Time Frame
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
Title
time of operation
Time Frame
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
Title
status of the resection margins
Time Frame
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
Title
bile leakage
Time Frame
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
Title
abdominal adhesion
Time Frame
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
Participants will be followed for 5 years.
Title
disease-free survival
Time Frame
Participants will be followed for 5 years.
Title
time to disease recurrence
Time Frame
Participants will be followed for 5 years.

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: Child-pugh A-B Primary hepatocellular carcinoma of the left liver lobe Tumor size ≤5cm in diameter KPS≥60 Exclusion Criteria: Significant abnormal liver function Significant abnormal Heart function Significant abnormal lung function Significant abnormal kidney function
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Jin Chen, M.D.
Phone
00862034071169
Email
drcaojun@163.com
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan-qing Zhou
Phone
00862081332371
Email
ywjgbgs@163.com

12. IPD Sharing Statement

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Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

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