Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- time of operation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Child-pugh A-B
- •Primary hepatocellular carcinoma of the left liver lobe
- •Tumor size ≤5cm in diameter
Exclusion Criteria
- •Significant abnormal liver function
- •Significant abnormal Heart function
- •Significant abnormal lung function
- •Significant abnormal kidney function
Outcomes
Primary Outcomes
time of operation
Time Frame: 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.
bile leakage
Time Frame: 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.
amount of bleeding
Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
Secondary Outcomes
- overall survival(Participants will be followed for 5 years.)
- disease-free survival(Participants will be followed for 5 years.)
- time to disease recurrence(Participants will be followed for 5 years.)
Investigators
Ya-jin Chen
Chief of the division of hepatobiliary surgery
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University