NCT06368349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
Last Updated

April 18, 2024

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

April 11, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

Liver transplantationimmune cell subtypeimmunosuppressant

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 190 Liver transplantation (LT) recipients were enrolled including 145 cases for retrospective and 45 cases for perspective

You may qualify if:

  • liver transplant patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Lymphopenia

Condition Hierarchy (Ancestors)

LeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 16, 2024

Study Start

March 1, 2022

Primary Completion

June 21, 2023

Study Completion

June 30, 2023

Last Updated

April 18, 2024

Record last verified: 2021-10

Locations