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

• ClinicalTrials.gov Identifier: NCT03652896
• Recruitment Status: Not yet recruiting
• First Posted: August 29, 2018
• Last Update Posted: August 29, 2018
• Sponsor: Huazhong University of Science and Technology
• Information provided by (Responsible Party): Xiaoping Chen, Huazhong University of Science and Technology

Tracking Information

• First Submitted Date: August 20, 2018
• First Posted Date: August 29, 2018
• Last Update Posted Date: August 29, 2018
• Estimated Study Start Date: January 1, 2019
• Estimated Primary Completion Date: December 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 27, 2018)

prognosis [ Time Frame: 5 years ]

3 year and 5 year overall survival and disease free survival

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: 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: 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hepatocellular Carcinoma by BCLC Stage

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 27, 2018): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2023
• Estimated Primary Completion Date: December 30, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 17 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Binhao Zhang, M.D.; +86 83663400; bhzhang8@163.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03652896
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Xiaoping Chen, Huazhong University of Science and Technology
• Study Sponsor: Huazhong University of Science and Technology
• Collaborators: Not Provided

Investigators

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

• PRS Account: Huazhong University of Science and Technology
• Verification Date: August 2018