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

NCT03652896 | Unknown DMC

• 1 other identifier: AR2018MR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma by BCLC Stage

Keywords

hepatocellular carcinoma; anatomical liver resection

Outcome Measures

Primary Outcomes (1)

• prognosis

  3 year and 5 year overall survival and disease free survival

  5 years

Secondary Outcomes (2)

• postoperative recovery

  30 days postoperatively

• hospital stay

  60 days postoperatively

Other Outcomes (3)

• surgery duration

  24 hours

• volume of bleeding

  24 hours

• volume of transfusion

  24 hours

Study Arms (2)

anatomical liver resection

EXPERIMENTAL

resect the tumor located liver segment or lobe

Procedure: anatomical liver resection

resection margin based liver resection

EXPERIMENTAL

non-anatomical liver resection, but insure adequate resection margin

Procedure: anatomical liver resection

Interventions

anatomical liver resection 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.

Also known as: non-anatomical liver resection

anatomical liver resection; resection margin based liver resection

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with hepatocellular carcinoma of BCLC stage A
• liver function Child-pugh A
• normal indocyanine green retention rate
• adequate liver remnant

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Hepatic Surgery Center of Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Xiaoping Chen, M.D.

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binhao Zhang, M.D.

CONTACT

+86 83663400; bhzhang8@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 29, 2018
• Study Start: January 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2023
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

CN (1)