End Stage Liver DIseaseOver70-LTNCT06382740
Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years
An observational study of End Stage Liver DIsease and Liver Transplantation, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several… Read more about this study
- Who is it for?
- Ages 71 to 75 years
- Conditions the study is for
- End Stage Liver DIsease, Liver Transplantation, Old Age
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 71 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Consecutive candidates for liver transplant with age >70 and ≤ 75 years
Who may be able to join
- Age >70 years and ≤ 75 years
- Liver transplant from cadaveric donor
- First liver transplant
- End stage liver disease or liver tumor
Who cannot join
- Age ≤ 70 years
- Living donor liver transplant
- Previous liver transplant
- Liver transplant for acute liver failure
Trial locations and contacts
1 site in 1 country.
Alessandro Vitale, Prof contact
Italy1 site, 1 recruiting
- Recruiting
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Padova, 35128
Umberto Cillo, MD, cillo@unipd.it
About this study
Official title: Prospective Evaluation of a Selection Protocol for Patients Over 70 Years Old for Liver Transplantation
Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.
This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.
- Conditions
- End Stage Liver DIsease, Liver Transplantation, Old Age
- Being tested
- Liver transplantation
- Keywords
- liver transplantation, old recipients, age>70 years
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Liver transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year patient survival
Overall patients survival at 12 months from liver transplantation
Measured: 12 months
Secondary outcomes (2)
1 year graft survival
Overall graft survival at 12 months from liver transplantation
Measured: 12 months
3 months mortality and morbidity
Mortality and morbidity rates at 3 months from liver transplantation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Umberto Cillo, Azienda Ospedaliera di Padova
- Investigators
- Umberto Cillo, Prof, Principal investigator, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382740
- Sponsor's protocol ID
- AOP2097
- Acronym
- Over70-LT
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Selection Protocol for Patients Over 70 Years Old for Liver Transplantation
- ClinicalTrials.gov ID
- NCT06382740
- Acronym / sponsor ID
- Over70-LT / AOP2097
- Conditions
- End Stage Liver DIsease, Liver Transplantation, Old Age
- Keywords
- liver transplantation, old recipients, age>70 years
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.
This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 71 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Consecutive candidates for liver transplant with age >70 and ≤ 75 years
Key inclusion criteria (4 listed)
- Age >70 years and ≤ 75 years
- Liver transplant from cadaveric donor
- First liver transplant
- End stage liver disease or liver tumor
Key exclusion criteria (4 listed)
- Age ≤ 70 years
- Living donor liver transplant
- Previous liver transplant
- Liver transplant for acute liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantationLiver transplantation | Procedure or surgery | – |
Primary outcome
1 year patient survival
Time frame: 12 months
Overall patients survival at 12 months from liver transplantation
2 secondary outcomes
1 year graft survival
Time frame: 12 months
3 months mortality and morbidity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Vitale, Prof contact
Umberto Cillo, Prof principal investigator
Azienda Ospedaliera di Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver DIsease and Liver Transplantation, run by Azienda Ospedaliera di Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto Cillo, Prof (049.8212211-1897, cillo@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year patient survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.