Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection

Study Overview
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Brief Summary
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This prospective non-randomized controlled trial aims to determine whether autotransfusion of red blood cells salvaged before liver resection is associated with the recurrence-free survival in patients with hepatocellular carcinoma.

Detailed Description
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Preoperative and intraoperative blood salvage autotransfusion is used in various surgical procedures. However, because of the risk of reinfusion of salvaged blood contaminated by tumor cells, the use of autotransfusion in hepatocellular carcinoma (HCC) patients undergoing liver resection is controversial. The critical points include whether tumor cells can be cleared by autotransfusion, whether autotransfusion increases the risk of recurrence or metastasis, and what are the indications for autotransfusion. Moreover, some other issues are still not addressed. For example, is it warranted to take the risk of tumor dissemination by using autotransfusion to avoid allogeneic blood transfusion? Do the remaining tumor cells after additional filtration by leukocyte depletion filters still possess potential tumorigenicity?

Official Title
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Association Between Autologous Transfusion and Recurrence-free Survival in Patients With Hepatocellular Carcinoma After Resection-a Prospective Non-randomized Controlled Trial

Conditions
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Liver Cancer

Intervention / Treatment
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* Procedure: Autotransfusion
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent liver resection; Diagnosis of hepatocellular carcinoma confirmed by postoperative histopathology; Level of preoperative hemoglobin ≥110 g/L; Child-Pugh class A or B liver function; Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. Exclusion Criteria: A history of other malignancies; History of active autoimmune or immunodeficiency diseases; Concurrent cardiac, pulmonary, cerebral, or renal dysfunction; Loss to follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autotransfusion group<br>These group of patients will receive autotransfusion before liver resection. | Procedure: Autotransfusion<br>* These group of patients will receive autotransfusion before liver resection.<br>|
| Active Comparator: Control group<br>These group of patients will not receive autotransfusion before liver resection. | Other: Control group<br>* These group of patients will not receive autotransfusion before liver resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with tumor recurrence | The 1-year tumor recurrence will be compared between the two groups | 1-year |