Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over

Patients Suitable for a Liver Transplant Clinical Trial

— LT 65+  

Official title:

Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754503
• Other study ID #: 2020-A03063-36
• Status: Recruiting
• Start date: April 9, 2021
• Est. completion date: April 2025

Study information

• Verified date: January 2023
• Source: Gérond'if
• Contact: Isabelle Dufour
• Phone: +33 (0)185781010
• Email: isabelle.dufour[@]gerondif.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this non-interventional, single-center study is to assess survival and associated factors at 1 year in patients aged 65 and over who received liver transplantation

Description:

The expected benefits of this study are to identify the preoperative risk factors of mortality from liver transplant failure in patients aged 65 and over (90-day mortality and 1 and 3-year survival) will allow better selection. candidates for this age group. In the current context of organ shortage, this study should make it possible to reduce the number of risky transplants and thus improve the allocation of grafts.Inclusion of patients who meet the inclusion criteria will be carried out during their hospitalization in the surgical department of the hepato-bilary center.

Included patients will receive a standardized geriatric assessment in addition to the usual assessment for a liver transplant.

The geriatric assessment will be carried out and conducted as follows: geriatric scores and quality of life questionnaires. Two geriatricians will perform the physical examination and blindly estimate each other's probability of survival at 90 days using a Likert scale.

Geriatricians will be blinded to hepatic data (reasons for transplantation). The consultation as well as the completion of the questionnaire will be carried out during the pre-transplantation assessment.

Survival and quality of life will be assessed at 3 and 12 months post-transplantaion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Candidates for liver transplantation

• Having expressed non-oppostion to his participation in study and documented in his medical file

• With social coverage

Exclusion Criteria:

• Emergency transplant patients

• Patient already included in another study

• Patient under guardianship or curatorship

• Expressing his opposition to participate in the study

Related Conditions & MeSH terms

• Patients Suitable for a Liver Transplant

Locations

Country	Name	City	State
France	Geriatric Department, Paul Brousse Hospital	Villejuif	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of commorbidity risk according Charlson score		At inclusion
Other	Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale		12 Months
Other	Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale		12 months
Other	Assessment of quality of life according the SF-36 Health Status Questionnaire		12 months
Other	Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale		12 months
Primary	Assessment of survival and quality of life after liver transplantation according to the quality of life score		12 Months
Secondary	Detecting depression in the elderly according the Geriatric Depression Scale (GDS)		12 Months