Liver TransplantationNCT04814290
Long-term Follow-up of Living Liver Donors: A Single-center Experience
An observational study of Liver Transplantation, run by Mansoura University.
Trial summary
Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
- How many people
- 476 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2004to 1 Jan 2021
- How long will I take part?
- 4 Years
- 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 18 to 50 years
- All sexes
- Adult
Study population: 237 living liver donors and 239 matched controls.
Who may be able to join
- age 18-50 years
- no comorbidities.
- BMI less than 30 kg/m2.
- compatible ABO group.
Who cannot join
- Older than 50 years.
- Associated comorbidities.
- Obesity.
- Noncompatible ABO group.
About this study
Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.
Read the detailed description
Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.
We used the 36-item short-form health survey (short form-36 health survey, version 1 [SF-36]). The scores for the 4 following subscales were higher in nondonors than in donors: physical functioning (P = 0.009), role limitations due to physical health (P = 0.002), energy/fatigue (P < 0.001), and bodily pain (P < 0.001). The scores on the 8 subscales of the SF-36 were higher in donors with living recipients than in donors whose recipients died (P < 0.001). Our results suggest that living donor right hepatectomy is safe and results in a postdonation HRQoL similar to that of nondonors in those donors whose recipients are healthy, while donors whose recipients die have a lower HRQoL that is significantly negatively correlated with the time since recipient death and improves over time.
- Conditions
- Liver Transplantation
- Being tested
- health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
- Keywords
- Living-donor liver transplantation, Quality of life, Follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).Other
health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
| Study group | Role | What they receive |
|---|---|---|
| living liver donors | cases already underwent hepatectomy for living-donor liver transplantation. Receives: Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]). | |
| matched controls | healthy persons who attended the preoperative clinic while preparing for donation but were rejected because of an ABO blood group mismatch. Receives: Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]). |
What is being measured
The primary outcome is the main question the study is designed to answer.
health-related quality of life (HRQoL)
health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
Measured: 4 to 16 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 May 2004
- Primary completion1 May 2014
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 476 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shehta, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814290
- Sponsor's protocol ID
- No. MD/15.08.50
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Privacy for liver transplantation unit, mansoura university.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Living Liver Donors: A Single-center Experience
- ClinicalTrials.gov ID
- NCT04814290
- Acronym / sponsor ID
- No. MD/15.08.50
- Conditions
- Liver Transplantation
- Keywords
- Living-donor liver transplantation, Quality of life, Follow up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2004 (actual)
- Primary completion
- 1 May 2014 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 24 Mar 2021 (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.
Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.
Detailed description
Data on the long-term consequences of living liver donation are scarce. This study examined clinical, laboratory, and radiological parameters and long-term health-related quality of life (HRQoL) in 237 living liver donors and 239 matched controls during 48 to 168 months of postdonation follow-up.
We used the 36-item short-form health survey (short form-36 health survey, version 1 [SF-36]). The scores for the 4 following subscales were higher in nondonors than in donors: physical functioning (P = 0.009), role limitations due to physical health (P = 0.002), energy/fatigue (P < 0.001), and bodily pain (P < 0.001). The scores on the 8 subscales of the SF-36 were higher in donors with living recipients than in donors whose recipients died (P < 0.001). Our results suggest that living donor right hepatectomy is safe and results in a postdonation HRQoL similar to that of nondonors in those donors whose recipients are healthy, while donors whose recipients die have a lower HRQoL that is significantly negatively correlated with the time since recipient death and improves over time.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| living liver donors | – | Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).cases already underwent hepatectomy for living-donor liver transplantation. |
| matched controls | – | Other: health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).healthy persons who attended the preoperative clinic while preparing for donation but were rejected because of an ABO blood group mismatch. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- 237 living liver donors and 239 matched controls.
Key inclusion criteria (4 listed)
- age 18-50 years
- no comorbidities.
- BMI less than 30 kg/m2.
- compatible ABO group.
Key exclusion criteria (4 listed)
- Older than 50 years.
- Associated comorbidities.
- Obesity.
- Noncompatible ABO group.
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 |
|---|---|---|
| health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]). | Other | living liver donors, matched controls |
Primary outcome
health-related quality of life (HRQoL)
Time frame: 4 to 16 years of follow up
health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: Undecided. Privacy for liver transplantation unit, mansoura university.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Mansoura University.
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: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health-related quality of life (HRQoL) (time frame: 4 to 16 years of follow up). 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 Mar 2021.