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Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection (AT/HCC)

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Autotransfusion
Control group
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who underwent open liver resection;
  • Level of preoperative hemoglobin ≥110 g/L.

Exclusion Criteria:

  • None

Sites / Locations

  • Affiliated Tumor Hospital of Guangxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autotransfusion group

Control group

Arm Description

These group of patients will receive autotransfusion before liver resection.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 10, 2016
Last Updated
January 21, 2023
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02654028
Brief Title
Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
618 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autotransfusion group
Arm Type
Experimental
Arm Description
These group of patients will receive autotransfusion before liver resection.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
These group of patients will not receive autotransfusion before liver resection.
Intervention Type
Procedure
Intervention Name(s)
Autotransfusion
Intervention Description
These group of patients will receive autotransfusion before liver resection.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
These group of patients will not receive autotransfusion before liver resection.
Primary Outcome Measure Information:
Title
Number of participants with tumor recurrence
Description
The 1-year tumor recurrence will be compared between the two groups
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-Hong Zhong, MD
Organizational Affiliation
Guangxi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Tumor Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
5350032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26501715
Citation
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.
Results Reference
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PubMed Identifier
24009154
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.
Results Reference
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PubMed Identifier
33914466
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.
Results Reference
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Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection

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