Clinical trial NCT04754503: Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over
Official title: Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Suitable for a Liver Transplant
Keywords: liver transplant
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 125
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 65 years of age who are candidates for a liver transplant at the participating center during the study period.

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of survival and quality of life after liver transplantation according to the quality of life score
timeFrame: 12 Months
Secondary outcomes:
measure: Detecting depression in the elderly according the Geriatric Depression Scale (GDS)
timeFrame: 12 Months
Other outcomes:
measure: Assessment of commorbidity risk according Charlson score
timeFrame: At inclusion
measure: Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
timeFrame: 12 Months
measure: Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
timeFrame: 12 months
measure: Assessment of quality of life according the SF-36 Health Status Questionnaire
timeFrame: 12 months
measure: Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
timeFrame: 12 months
Locations:
city: Villejuif
country: France
facility: Geriatric Department, Paul Brousse Hospital
state: Île-de-France
Study officials:
affiliation: Geriatric Department, Paul Brousse Hospital
name: Duron Emmanuelle, MD PhD
role: STUDY_CHAIR
References: