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

Not Applicable

Completed

• Conditions: Liver Cancer
• Interventions: Other: Control group; Procedure: Autotransfusion

• Registration Number: NCT02654028
• Lead Sponsor: Guangxi Medical University

Brief Summary

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

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?

Study Timeline

• Study First Submitted: 2016-01-10
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-13
• Study Start: 2019-01-05
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	These group of patients will not receive autotransfusion before liver resection.
Autotransfusion group	Autotransfusion	These group of patients will receive autotransfusion before liver resection.

Primary Outcome Measures

Name	Time	Method
Number of participants with tumor recurrence	1-year	The 1-year tumor recurrence will be compared between the two groups

Trial Locations

Locations (1)

Affiliated Tumor Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China