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Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma

H

Huazhong University of Science and Technology

Status

Unknown

Conditions

Hepatocellular Carcinoma by BCLC Stage

Treatments

Procedure: anatomical liver resection

Study type

Interventional

Funder types

Other

Identifiers

NCT03652896
AR2018MR

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

17 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

anatomical liver resection
Experimental group
Description:
resect the tumor located liver segment or lobe
Treatment:
Procedure: anatomical liver resection
resection margin based liver resection
Experimental group
Description:
non-anatomical liver resection, but insure adequate resection margin
Treatment:
Procedure: anatomical liver resection

Trial contacts and locations

1

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Central trial contact

Binhao Zhang, M.D.

Data sourced from clinicaltrials.gov

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