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

Liver Cancer Clinical Trial

— AT/HCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654028
• Other study ID #: AT/HCC
• Status: Completed
• Phase: N/A
• Start date: January 5, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2023
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Recurrence

Intervention

Procedure:
• Autotransfusion
These group of patients will receive autotransfusion before liver resection.

Other:
• Control group
These group of patients will not receive autotransfusion before liver resection.

Locations

Country	Name	City	State
China	Affiliated Tumor Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Han S, Kim G, Ko JS, Sinn DH, Yang JD, Joh JW, Lee SK, Gwak MS. Safety of the Use of Blood Salvage and Autotransfusion During Liver Transplantation for Hepatocellular Carcinoma. Ann Surg. 2016 Aug;264(2):339-43. doi: 10.1097/SLA.0000000000001486. — View Citation

Kwon JH, Han S, Kim D, Kuk JH, Cho H, Kim S, Yang JD, Kim C, Kim JM, Choi GS, Joh JW, Ko JS, Gwak MS, Kim G. Blood Salvage and Autotransfusion With Single Leukoreduction Does Not Increase the Risk of Tumor Recurrence After Liver Transplantation for Advanced Hepatocellular Carcinoma. Ann Surg. 2022 Dec 1;276(6):e842-e850. doi: 10.1097/SLA.0000000000004866. Epub 2021 Mar 18. — View Citation

Tomimaru Y, Eguchi H, Wada H, Hama N, Kawamoto K, Kobayashi S, Umeshita K, Doki Y, Mori M, Nagano H. Predicting the necessity of autologous blood collection and storage before surgery for hepatocellular carcinoma. J Surg Oncol. 2013 Dec;108(7):486-91. doi: 10.1002/jso.23426. Epub 2013 Sep 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with tumor recurrence	The 1-year tumor recurrence will be compared between the two groups	1-year