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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-05

Study Completion Date

2021-12-30

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.

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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?

Conditions

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Liver Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Autotransfusion group

These group of patients will receive autotransfusion before liver resection.

Group Type EXPERIMENTAL

Autotransfusion

Intervention Type PROCEDURE

These group of patients will receive autotransfusion before liver resection.

Control group

These group of patients will not receive autotransfusion before liver resection.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

These group of patients will not receive autotransfusion before liver resection.

Interventions

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Autotransfusion

These group of patients will receive autotransfusion before liver resection.

Intervention Type PROCEDURE

Control group

These group of patients will not receive autotransfusion before liver resection.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes