Hepatocellular Carcinoma by BCLC Stage
Conditions
Keywords
hepatocellular carcinoma, anatomical liver resection
Brief summary
Anatomical liver resection was widely accepted as first line curative therapy for hepatocellular carcinoma. However, number of retrospective clinical studies showed no priority of anatomical resection for hepatocellular, compared with non-anatomical resection. Surgical resection margin is a essential factor that may affect tumor prognosis. It is controversial whether adequate liver resection margin is associated with improved survival outcome in patients with hepatocellular. There was few prospective clinical trial to investigate whether anatomical liver resection is superior to non-anatomical resection or liver resection with adequate margin is superior to that with inadequate margin. This prospective clinical trial aims at fix these issues.
Detailed description
In the anatomical liver resection group, liver segmentectomy or lobectomy is performed to insure curative resection (R0 resection). The region of liver resected is based on the anatomy or portal vein and hepatic vein. The liver pedicle of the tumor located lobe is exposed and dissected, which is principle to perform anatomical liver resection. In the non-anatomical liver resection group, the liver parenchyma transection is around 0-2 cm from the tumor margin, according to tumor size and location.
Interventions
PROCEDUREanatomical liver resection
Liver resection is performed to achieve R0 resection for patients with appropriate BCLC staging, indocyanine green retention rate, Child-pugh grading and adequate liver remnant.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients diagnosed with hepatocellular carcinoma of BCLC stage A * liver function Child-pugh A * normal indocyanine green retention rate * adequate liver remnant
Exclusion criteria
* age less than 17 y or older than 65 y * unresectable liver cancer * intraoperative ablation * contraindication for liver resection * preoperative treatment for hepatocellular * active hepatitis * pregnant * multi-original tumors * mixed liver cancer (hepatocellular carcinoma and cholangiocellular carcinoma) * tumor recurrence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prognosis | 5 years | 3 year and 5 year overall survival and disease free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative recovery | 30 days postoperatively | postoperative complications |
| hospital stay | 60 days postoperatively | hospital days after operation |
Other
| Measure | Time frame | Description |
|---|---|---|
| surgery duration | 24 hours | time duration of liver parenchyma transection |
| volume of bleeding | 24 hours | millilitre of blood lost during operation |
| volume of transfusion | 24 hours | units of blood transfusion |
Countries
China
Contacts
Primary ContactBinhao Zhang, M.D.
Outcome results
None listed