Clinical trial NCT02654028: Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection
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
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?

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.

Primary outcomes:
measure: Number of participants with tumor recurrence
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanning
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: Guangxi Medical University
name: Jian-Hong Zhong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.