Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma
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.
Interventions
PROCEDURELaparoscopic liver resection
participants will be performed with laparoscopic hepatectomy using laparoscopic instruments
PROCEDUREOpen liver resection
participants will be performed with open hepatectomy using laparotomic instruments
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total survival time and disease free survival time | up to 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical margins | 7 days | — |
| Time to functional recovery | participants will be followed for the duration of hospital stay, an expected average of 6 days | — |
| Postoperative hospital stay | participants will be followed for the duration of hospital stay, an expected average of 7 days | — |
| Morbidity and mortality | up to 3 months | — |
| Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor | participants will be followed for the duration of operation, an expected average of 90 min | — |
| Regulatory T cells and associated cytokines in peripheral blood | up to 5 years | 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 | 7 days | — |
| Quality of life | up to 1 year | — |
Other
| Measure | Time frame |
|---|---|
| Hospital costs | participants will be followed for the duration of hospital stay, an expected average of 9 days |
Countries
China
Contacts
Primary ContactXiujun Cai, MD
Outcome results
None listed