Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652896
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoping Chen, Huazhong University of Science and Technology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma by BCLC Stage Procedure: anatomical liver resection Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: non-anatomical liver resection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. prognosis [ Time Frame: 5 years ]
    3 year and 5 year overall survival and disease free survival


Secondary Outcome Measures :
  1. postoperative recovery [ Time Frame: 30 days postoperatively ]
    postoperative complications

  2. hospital stay [ Time Frame: 60 days postoperatively ]
    hospital days after operation


Other Outcome Measures:
  1. surgery duration [ Time Frame: 24 hours ]
    time duration of liver parenchyma transection

  2. volume of bleeding [ Time Frame: 24 hours ]
    millilitre of blood lost during operation

  3. volume of transfusion [ Time Frame: 24 hours ]
    units of blood transfusion


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652896


Contacts
Layout table for location contacts
Contact: Binhao Zhang, M.D. +86 83663400 bhzhang8@163.com

Locations
Layout table for location information
China, Hubei
Hepatic Surgery Center of Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Layout table for investigator information
Principal Investigator: Xiaoping Chen, M.D. Huazhong University of Science and Technology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Xiaoping Chen, Professor and Chairman, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03652896    
Other Study ID Numbers: AR2018MR
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaoping Chen, Huazhong University of Science and Technology:
hepatocellular carcinoma
anatomical liver resection
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics