Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103097
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-15
Brief Title:
Histologic Evolution of Patients With Liver Transplantation
Sponsor:
Hospital Vall dHebron
Organization:
Hospital Vall dHebron
Study Overview
Official Title:
Assessment of the Histological Evolution of Pediatric Patients With Liver Transplantation
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Certain pediatric liver transplant patients with immunosuppression levels in the therapeutic range and normal liver function tests present histological alterations inflammation or fibrosis in protocol biopsies
The objective of the study was to evaluate the histological findings of protocol biopsies performed at 2 5 10 and 15 years after liver transplantation in pediatric patients A follow-up biopsy is also performed 1 and 3 years after liver rejection
To do that a cohort study will be carried out by collecting clinical analytical and histological data of patients undergoing post-liver transplant follow-up in pediatric hepatology and liver transplant outpatient clinics According to the follow-up protocol for these patients a liver biopsy is performed at 2 5 10 and 15 years after the transplant In addition ultrasound elastography and general analysis with autoimmunity and HLA studies are carried out
The evaluation of the histological evolution of the liver graft and its relationship with clinical and analytical changes will favor the management of immunosuppressive treatment in pediatric patients with liver transplants
The objective of the study was to evaluate the histological findings of protocol biopsies performed at 2 5 10 and 15 years after liver transplantation in pediatric patients A follow-up biopsy is also performed 1 and 3 years after liver rejection
To do that a cohort study will be carried out by collecting clinical analytical and histological data of patients undergoing post-liver transplant follow-up in pediatric hepatology and liver transplant outpatient clinics According to the follow-up protocol for these patients a liver biopsy is performed at 2 5 10 and 15 years after the transplant In addition ultrasound elastography and general analysis with autoimmunity and HLA studies are carried out
The evaluation of the histological evolution of the liver graft and its relationship with clinical and analytical changes will favor the management of immunosuppressive treatment in pediatric patients with liver transplants
Detailed Description:
Given the increase in survival of both the graft and the transplanted patient new questions arise regarding long-term follow-up In general transplant patients undergo follow-up visits that include blood tests and abdominal ultrasounds Immunosuppression levels graft function and possible complications infectious tumorous acute or chronic rejection renal are monitored
The use of immunosuppressants is mainly associated with renal infectious complications and de novo cancer However insufficient levels of immunosuppression can lead to graft rejection On the one hand various authors have attempted to completely withdraw immunosuppressive treatment in selected patients On the other hand histological alterations have been evidenced in patients with normal liver function tests and who maintained serum levels of immunosuppression in the therapeutic range The balance between these two situations in not always easy
Hypothesis
Certain pediatric liver transplant patients with immunosuppression levels in the therapeutic range and normal liver function tests present histological alterations inflammation or fibrosis in protocol biopsies
Main objetive
To evaluate the histological findings of protocol biopsies performed at 2 5 10 and 15 years after liver transplantation in pediatric patients
STUDY PROTOCOL
Retrospective data collection through review of medical records of pediatric liver transplant patients who meet the inclusion criteria For the protection of personal data the data collection form will under no circumstances contain the name or NHC only the date of birth weight and gender of the patient will be referenced Each patient will be uniquely identified by an identification number ID that will be automatically administered by the same computer program The correlation between the coding and the patients personal information will be kept in written format and under lock and key in the Vall dHebron Hospital facilities The demographic clinical analytical ultrasound elastographic and biopsy data of the patients will be collected With the data collected a database will be created that allows its analysis The platform used to collect said data will be Certain-Li complying with the coding requirements for patient anonymity This is a platform developed within the framework of the international working group Graft Injury Group observing long term outcomes
LT Follow-Up All patients received immunosuppressant treatment according to our standard protocol in accordance with current European guidelines To monitor graft function liver function tests were measured every 2-3 months and Doppler Ultrasound was performed annually Liver stiffness was assessed by transient elastography TE using FibroScan Echosens Paris France with a pediatric S or adult M probe as appropriate TE evaluations were performed annually and whenever a follow-up biopsy was performed
Follow-up liver biopsies Follow-up liver biopsies were obtained from patients with normal liver function tests to control histopathological changes at 2 5 10 and 15 years after transplantation and just before transition to adult care aged 18 to 20 years Diagnosis of acute liver rejection was always made by biopsy BPAR and rejection was graded using the Rejection Activity Index RAI score according to the Banff classification The fibrosis stage was assessed using the ISHAK score 0-6 in every liver biopsy
Statistical study All data collected in this registry will be provided in patient data listings Summary tables andor graphs will be presented for the selected parameters as appropriate to the data
For descriptive analyses continuous patient variables will be expressed as mean and standard deviation or median and interquartile range depending on the nature of each variable For continuous variables the Sudent t test for independent samples will be used or the Mann Whitney U test when the variable does not follow a normal distribution Fishers exact test or the Chi-square test was used for discrete variables The differences will be considered statistically significant with a p005 two-sided contrast To evaluate the correlation between the follow-up time and the different variables that show liver involvement the Pearson or Spearman coefficient will be used depending on whether or not they follow a normal distribution respectively The correlation coefficients will be interpreted according to the guidelines of Fleiss et al being classified as excellent when R 075 good if 040 R 075 or poor if R 040 Statistical analyzes will be performed using SPSS statistical software version 180 SPSS Corporation Chicago IL USA
The use of immunosuppressants is mainly associated with renal infectious complications and de novo cancer However insufficient levels of immunosuppression can lead to graft rejection On the one hand various authors have attempted to completely withdraw immunosuppressive treatment in selected patients On the other hand histological alterations have been evidenced in patients with normal liver function tests and who maintained serum levels of immunosuppression in the therapeutic range The balance between these two situations in not always easy
Hypothesis
Certain pediatric liver transplant patients with immunosuppression levels in the therapeutic range and normal liver function tests present histological alterations inflammation or fibrosis in protocol biopsies
Main objetive
To evaluate the histological findings of protocol biopsies performed at 2 5 10 and 15 years after liver transplantation in pediatric patients
STUDY PROTOCOL
Retrospective data collection through review of medical records of pediatric liver transplant patients who meet the inclusion criteria For the protection of personal data the data collection form will under no circumstances contain the name or NHC only the date of birth weight and gender of the patient will be referenced Each patient will be uniquely identified by an identification number ID that will be automatically administered by the same computer program The correlation between the coding and the patients personal information will be kept in written format and under lock and key in the Vall dHebron Hospital facilities The demographic clinical analytical ultrasound elastographic and biopsy data of the patients will be collected With the data collected a database will be created that allows its analysis The platform used to collect said data will be Certain-Li complying with the coding requirements for patient anonymity This is a platform developed within the framework of the international working group Graft Injury Group observing long term outcomes
LT Follow-Up All patients received immunosuppressant treatment according to our standard protocol in accordance with current European guidelines To monitor graft function liver function tests were measured every 2-3 months and Doppler Ultrasound was performed annually Liver stiffness was assessed by transient elastography TE using FibroScan Echosens Paris France with a pediatric S or adult M probe as appropriate TE evaluations were performed annually and whenever a follow-up biopsy was performed
Follow-up liver biopsies Follow-up liver biopsies were obtained from patients with normal liver function tests to control histopathological changes at 2 5 10 and 15 years after transplantation and just before transition to adult care aged 18 to 20 years Diagnosis of acute liver rejection was always made by biopsy BPAR and rejection was graded using the Rejection Activity Index RAI score according to the Banff classification The fibrosis stage was assessed using the ISHAK score 0-6 in every liver biopsy
Statistical study All data collected in this registry will be provided in patient data listings Summary tables andor graphs will be presented for the selected parameters as appropriate to the data
For descriptive analyses continuous patient variables will be expressed as mean and standard deviation or median and interquartile range depending on the nature of each variable For continuous variables the Sudent t test for independent samples will be used or the Mann Whitney U test when the variable does not follow a normal distribution Fishers exact test or the Chi-square test was used for discrete variables The differences will be considered statistically significant with a p005 two-sided contrast To evaluate the correlation between the follow-up time and the different variables that show liver involvement the Pearson or Spearman coefficient will be used depending on whether or not they follow a normal distribution respectively The correlation coefficients will be interpreted according to the guidelines of Fleiss et al being classified as excellent when R 075 good if 040 R 075 or poor if R 040 Statistical analyzes will be performed using SPSS statistical software version 180 SPSS Corporation Chicago IL USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None