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

Lymphopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06368349
• Other study ID #: 202101771B0
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 30, 2023
• Est. primary completion date: June 21, 2023
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Lymphopenia

Locations

Country	Name	City	State
Taiwan	Department of Surgery	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent lymphopenia predict poor overall survival	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.	From 2006 to 2019
Primary	T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient	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.	From March 2022 to June 2023
Primary	Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use	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.	From 2006 to 2019