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

Not Applicable

• Conditions: Hepatocellular Carcinoma by BCLC Stage
• Interventions: Procedure: anatomical liver resection

• Registration Number: NCT03652896
• Lead Sponsor: Huazhong University of Science and Technology

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 Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-27
• Last Update Submitted: 2018-08-27
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29
• Study Start: 2019-01-01
• Primary Completion: 2021-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resection margin based liver resection	anatomical liver resection	non-anatomical liver resection, but insure adequate resection margin
anatomical liver resection	anatomical liver resection	resect the tumor located liver segment or lobe

Primary Outcome Measures

Name	Time	Method
prognosis	5 years	3 year and 5 year overall survival and disease free survival

Secondary Outcome Measures

Name	Time	Method
postoperative recovery	30 days postoperatively	postoperative complications
hospital stay	60 days postoperatively	hospital days after operation

Trial Locations

Locations (1)

Hepatic Surgery Center of Tongji Hospital; 🇨🇳 Wuhan, Hubei, China