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Carcinoma, Hepatocellular

Liver Neoplasms

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Liver Extracts

These group of patients will receive autotransfusion before liver resection.

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

Autotransfusion

Control group

Jian-Hong Zhong, MD

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.

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?

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

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

The 1-year tumor recurrence will be compared between the two groups

Guangxi Medical University

Director

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

patients in this arm will receive their salvaged and washed RBCs via transfusion

patients in this arm will have their salvaged and washed RBCs discarded.

blood is collected from the surgical field, washed, processed and transfused back into the patient

Gonzalo Sapisochin, MD, PhD

This single-centre randomized pilot study will investigate the feasibility, safety, and efficacy of IBSA (intraoperative blood cell salvage and autotransfusion -when a patient's own blood is collected from the surgical field, washed, and transfused back to them), in patients undergoing Liver transplantation for Hepatocellular carcinoma (HCC).

A total of 30 patient participants will be enrolled. A participant will be randomized only if enough blood is collected during the transplant surgery to produce a minimum of 1 unit of autologous blood. Patients will be randomized to receive their blood back (via transfusion) or have their own blood discarded. Patients will be followed after surgery for evaluation of safety and efficacy.

Depending on the outcomes of this feasibility trial, a subsequent larger full-scale multi-institutional trial will be planned, which will be more appropriately powered to evaluate the true impact of IBSA on the use of allogeneic blood products and post-transplant HCC-specific outcomes.

Blood loss during liver transplantation (LT) often necessitates transfusion. However, allogeneic blood transfusion (blood from a donor) has risks. For this reason, intraoperative blood cell salvage and autotransfusion (IBSA) is frequently deployed to reduce the need for allogeneic blood transfusion. While IBSA is often used in LT, it is rarely used in patients undergoing LT for hepatocellular carcinoma (HCC) due to the theoretical risk of re-infusing cancer cells.

This single-centre, randomized, pilot study, will investigate the feasibility, safety, and efficacy of IBSA in patients undergoing LT for HCC.

Patients with HCC, listed for a Liver Transplant at the study institution, will be consented in clinic. At the time of liver transplant surgery, patients will be randomized, provided that enough blood is collected to generate a minimum of 1 unit of washed RBCs to give back. Participants randomized to arm 1 will receive their autologous blood via transfusion. Participants randomized to arm 2 will not receive their autologous blood - instead the blood will be discarded. Following surgery, participants will be followed for evaluation of safety and efficacy outcomes related to overall transfusions requirements and cancer recurrence.

The primary outcome is an evaluation of how many patients who consent to the trial will experience enough blood loss during surgery to be randomizable according to the study design (producing a minimum of 1 unit of washed RBCs).

Secondary outcomes include: whether the study can meet its accrual and enrollment goals within the study period; a comparison of rates of patient survival and HCC recurrence between the study groups; a comparison of the patient characteristics of those randomized to those not randomized. Blood will also be collected for correlative studies.

Depending on the outcomes of this feasibility trial, a subsequent larger full-scale multi-institutional trial will be planned, which will be more appropriately powered to evaluate the true impact of IBSA on the use of allogeneic blood products and post-transplant HCC-specific outcomes.

Blood Salvage in Orthotopic Liver Transplantation With HCC

Blood Salvage in Orthotopic Liver Transplantation With HCC: A Randomized Open-labelled Trial of Effectiveness & Safety (SOLT Trial) - A Pilot Trial

The primary outcome is an evaluation of how many patients who consent to the trial will experience enough blood loss during surgery to be randomizable according to the study design. This will be measured by comparing the number of consented patients undergoing LT who meet randomization requirements compared to those who do not.

to determine whether we can meet enrollment goals within the study period

compare rates of HCC recurrence between groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection	NCT02654028	Liver Cancer	Autotransfusion Control group	18 Years - 75 Years	Guangxi Medical University
Blood Salvage in Orthotopic Liver Transplantation With HCC	NCT05612477	Hepatocellular ... Surgery	Autotransfusion	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for autotransfusion