Clinical trial NCT06368349: Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma
Official title: Persistent Lymphopenia as a Prognostic Indicator in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphopenia
Keywords: Liver transplantation
immune cell subtype
immunosuppressant
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 190 Liver transplantation (LT) recipients were enrolled including 145 cases for retrospective and 45 cases for perspective

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.

Eligibility criteria: 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

Primary outcomes:
measure: Persistent lymphopenia predict poor overall survival
timeFrame: From 2006 to 2019
measure: T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient
timeFrame: From March 2022 to June 2023
measure: Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use
timeFrame: From 2006 to 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Surgery
Study officials:
References: