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

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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

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date August 29, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
prognosis [ Time Frame: 5 years ]
3 year and 5 year overall survival and disease free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • postoperative recovery [ Time Frame: 30 days postoperatively ]
    postoperative complications
  • hospital stay [ Time Frame: 60 days postoperatively ]
    hospital days after operation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 27, 2018)
  • surgery duration [ Time Frame: 24 hours ]
    time duration of liver parenchyma transection
  • volume of bleeding [ Time Frame: 24 hours ]
    millilitre of blood lost during operation
  • volume of transfusion [ Time Frame: 24 hours ]
    units of blood transfusion
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma
Official Title  ICMJE Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma by BCLC Stage
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: anatomical liver resection
    resect the tumor located liver segment or lobe
    Intervention: Procedure: anatomical liver resection
  • Experimental: resection margin based liver resection
    non-anatomical liver resection, but insure adequate resection margin
    Intervention: Procedure: anatomical liver resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Binhao Zhang, M.D. +86 83663400 bhzhang8@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03652896
Other Study ID Numbers  ICMJE AR2018MR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiaoping Chen, Huazhong University of Science and Technology
Study Sponsor  ICMJE Huazhong University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiaoping Chen, M.D. Huazhong University of Science and Technology
PRS Account Huazhong University of Science and Technology
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP