Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- prognosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
- •multi-original tumors
- •mixed liver cancer (hepatocellular carcinoma and cholangiocellular carcinoma)
- •tumor recurrence
Arms & Interventions
anatomical liver resection
resect the tumor located liver segment or lobe
Intervention: anatomical liver resection (Procedure)
resection margin based liver resection
non-anatomical liver resection, but insure adequate resection margin
Intervention: anatomical liver resection (Procedure)
Outcomes
Primary Outcomes
prognosis
Time Frame: 5 years
3 year and 5 year overall survival and disease free survival
Secondary Outcomes
- postoperative recovery(30 days postoperatively)
- hospital stay(60 days postoperatively)
Investigators
Xiaoping Chen
Professor and Chairman
Huazhong University of Science and Technology