Hepatocellular Carcinoma, Laparoscopic Hepatectomy
Conditions
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.
Interventions
PROCEDURElaparoscopic hepatectomy
PROCEDUREopen liver resection
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| abdominal adhesion | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. |
| time of operation | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. |
| status of the resection margins | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. |
| bile leakage | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. |
| amount of bleeding | Participants will be observed for the duration of hospital stay, an expected average of 4 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival | Participants will be followed for 5 years. |
| time to disease recurrence | Participants will be followed for 5 years. |
| overall survival | Participants will be followed for 5 years. |
Countries
China
Contacts
Primary ContactYa-Jin Chen, M.D.
Outcome results
None listed