- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02131441
Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection
May 2, 2014 updated by: Ya-jin Chen, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
2
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 Contact
- Name: Ya-Jin Chen, M.D.
- Phone Number: 00862034071169
- Email: drcaojun@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Recruiting
- Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
-
Contact:
- Yan-qing Zhou
- Phone Number: 00862081332371
- Email: ywjgbgs@163.com
-
-
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:
- 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
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: laparoscopic hepatectomy
|
|
Other: open liver resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
amount of bleeding
Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
time of operation
Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
status of the resection margins
Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
bile leakage
Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
abdominal adhesion
Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: Participants will be followed for 5 years.
|
Participants will be followed for 5 years.
|
disease-free survival
Time Frame: Participants will be followed for 5 years.
|
Participants will be followed for 5 years.
|
time to disease recurrence
Time Frame: Participants will be followed for 5 years.
|
Participants will be followed for 5 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
July 1, 2013
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
April 29, 2014
First Submitted That Met QC Criteria
May 2, 2014
First Posted (Estimate)
May 6, 2014
Study Record Updates
Last Update Posted (Estimate)
May 6, 2014
Last Update Submitted That Met QC Criteria
May 2, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLLLR-001
- 2013005 (Other Grant/Funding Number: Clinical Research Program 5010 of Sun Yat-sen University)
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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