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

Primary Purpose

Hepatocellular Carcinoma by BCLC Stage

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anatomical liver resection
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma by BCLC Stage focused on measuring hepatocellular carcinoma, anatomical liver resection

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hepatic Surgery Center of Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

anatomical liver resection

resection margin based liver resection

Arm Description

resect the tumor located liver segment or lobe

non-anatomical liver resection, but insure adequate resection margin

Outcomes

Primary Outcome Measures

prognosis
3 year and 5 year overall survival and disease free survival

Secondary Outcome Measures

postoperative recovery
postoperative complications
hospital stay
hospital days after operation

Full Information

First Posted
August 20, 2018
Last Updated
August 27, 2018
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03652896
Brief Title
Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma
Official Title
Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma by BCLC Stage
Keywords
hepatocellular carcinoma, anatomical liver resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anatomical liver resection
Arm Type
Experimental
Arm Description
resect the tumor located liver segment or lobe
Arm Title
resection margin based liver resection
Arm Type
Experimental
Arm Description
non-anatomical liver resection, but insure adequate resection margin
Intervention Type
Procedure
Intervention Name(s)
anatomical liver resection
Other Intervention Name(s)
non-anatomical liver resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
prognosis
Description
3 year and 5 year overall survival and disease free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
postoperative recovery
Description
postoperative complications
Time Frame
30 days postoperatively
Title
hospital stay
Description
hospital days after operation
Time Frame
60 days postoperatively
Other Pre-specified Outcome Measures:
Title
surgery duration
Description
time duration of liver parenchyma transection
Time Frame
24 hours
Title
volume of bleeding
Description
millilitre of blood lost during operation
Time Frame
24 hours
Title
volume of transfusion
Description
units of blood transfusion
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binhao Zhang, M.D.
Phone
+86 83663400
Email
bhzhang8@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen, M.D.
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatic Surgery Center of Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

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

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