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

Hepatocellular Carcinoma by BCLC Stage Clinical Trial

Official title:

Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03652896
• Other study ID #: AR2018MR
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2018
• Source: Huazhong University of Science and Technology
• Contact: Binhao Zhang, M.D.
• Phone: +86 83663400
• Email: bhzhang8[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma by BCLC Stage

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Hepatic Surgery Center of Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	surgery duration	time duration of liver parenchyma transection	24 hours
Other	volume of bleeding	millilitre of blood lost during operation	24 hours
Other	volume of transfusion	units of blood transfusion	24 hours
Primary	prognosis	3 year and 5 year overall survival and disease free survival	5 years
Secondary	postoperative recovery	postoperative complications	30 days postoperatively
Secondary	hospital stay	hospital days after operation	60 days postoperatively