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NCT Number: NCT06368349

Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma

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.

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Key information

Conditions

Lymphopenia Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Leukocyte Disorders Leukopenia

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery

Kaohsiung City, 833, Taiwan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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