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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma by BCLC Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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anatomical liver resection

resect the tumor located liver segment or lobe

Group Type EXPERIMENTAL

anatomical liver resection

Intervention Type PROCEDURE

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.

resection margin based liver resection

non-anatomical liver resection, but insure adequate resection margin

Group Type EXPERIMENTAL

anatomical liver resection

Intervention Type PROCEDURE

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.

Interventions

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anatomical 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.

Intervention Type PROCEDURE

Other Intervention Names

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non-anatomical liver resection

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No