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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma by BCLC Stage
• Intervention / Treatment: Procedure: anatomical liver resection

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Binhao Zhang, M.D.; Phone Number: +86 83663400; Email: bhzhang8@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Hepatic Surgery Center of Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anatomical liver resection; resect the tumor located liver segment or lobe	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.; Other Names: non-anatomical liver resection
Experimental: resection margin based liver resection; non-anatomical liver resection, but insure adequate resection margin	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.; Other Names: non-anatomical liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prognosis	3 year and 5 year overall survival and disease free survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative recovery	postoperative complications	30 days postoperatively
hospital stay	hospital days after operation	60 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery duration	time duration of liver parenchyma transection	24 hours
volume of bleeding	millilitre of blood lost during operation	24 hours
volume of transfusion	units of blood transfusion	24 hours

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Xiaoping Chen, M.D., Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; anatomical liver resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Hematinics; Liver Extracts
• Other Study ID Numbers: AR2018MR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No