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Clinical Trials/NCT06368349
NCT06368349CompletedNot Applicable

Persistent Lymphopenia as a Prognostic Indicator in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma Recipients

Chang Gung Memorial Hospital1 site in 1 country190 target enrollmentStarted: March 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
190
Locations
1
Primary Endpoint
Persistent lymphopenia predict poor overall survival

Study Overview

Brief Summary

A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry.

Detailed Description

A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed including overall survival, recurrence-free survival, association between clinical parameter with mortality, patient characteristics by pre-lymphopenia and post-lymphopenia levels and lymphocyte status of HCC patients with usage of different immunosuppressants. In prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry to identify the major immune cell subsets and the characteristics of patients in the prospective cohort between pre-LT lymphopenia and non-lymphopenia groups.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • liver transplant patient

Exclusion Criteria

  • End-stage liver disease scoring system score (MELD score) > 25
  • Have received care in the intensive care unit (ICU) before transplantation
  • Poor cardiovascular function.
  • Patients suffering active infection.
  • Other complications affecting living donor liver transplantation

Outcomes

Primary Outcomes

Persistent lymphopenia predict poor overall survival

Time Frame: From 2006 to 2019

The clinical records of 145 patients with HCC from seven days pre-LT to one-year post-LT illustrated that the longitudinal values of lymphocytes were persistently low in patients with peritransplant high neutrophil lymphocyte ratio, indicating a significant decrease in survival rate when compared to other patients.

T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient

Time Frame: From March 2022 to June 2023

A significant decrease in cell counts and percentage of overall T cells in the peritransplant lymphopenia group. In particular, the counts of T cell subsets, T helper cells, and cluster of differentiation 8 (CD8+) cytotoxic/activated T cells significantly decreased in the peritransplant lymphopenia group with all of their naïve, effector, and memory forms.

Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use

Time Frame: From 2006 to 2019

In the subset of 116 of 145 HCC recipients (80%) who did not experience or recover from lymphopenia, no significant associations were observed with immunosuppressant use. Surprisingly, HCC recipients with long-term peritransplant lymphopenia exhibited a significant association with increased sirolimus use (p = 0.024) and decreased tacrolimus use (p = 0.001), whereas those with post-LT lymphopenia showed no association with the use of different immunosuppressants.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chang Gung Memorial Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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