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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial

Conditions
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Hepatocellular Carcinoma by BCLC Stage

Intervention / Treatment
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* Procedure: anatomical liver resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anatomical liver resection<br>resect the tumor located liver segment or lobe | Procedure: anatomical liver resection<br>* 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.<br>* Other names: non-anatomical liver resection;|
| Experimental: resection margin based liver resection<br>non-anatomical liver resection, but insure adequate resection margin | Procedure: anatomical liver resection<br>* 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.<br>* Other names: non-anatomical liver resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognosis | 3 year and 5 year overall survival and disease free survival | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative recovery | postoperative complications | 30 days postoperatively | 
| hospital stay | hospital days after operation | 60 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, anatomical liver resection