Liver Transplant; ComplicationsNCT04885582
The Relationship Between HLA Tissue Compatibility and Biliary Complications in Patients With Liver Transplantation
An observational study of Liver Transplant; Complications and HLA Antigens, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Liver transplantation has become the accepted treatment option for advanced liver failure in recent years. In addition to the increase in the number of centers performing transplant and the decrease in complication rates depending on the experience gained, the most common biliary complications did not improve at the… Read more about this study
- Who is it for?
- Ages 1 year to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant; Complications, HLA Antigens
- What is being tested?
- HLA antigen results
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2017to 20 May 2020
- 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 1 year to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who had liver transplantation and HLA tissue tests between 2017 and 2019 at Inonu University liver transplant institute
Who may be able to join
- patients with liver transplantation and tested for HLA antigen (recipient - donor)
Who cannot join
- patients who died early Patients whose HLA antigen is not checked
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health science University - Kayseri State Hospital
Kocasinan, Kayseri
About this study
Liver transplantation has become the accepted treatment option for advanced liver failure in recent years. In addition to the increase in the number of centers performing transplant and the decrease in complication rates depending on the experience gained, the most common biliary complications did not improve at the desired level. For this reason, studies in this field are frequent today.
The structural complexities of HLA antigens have been the subject of investigation in recent years. With the development of DNA and RNA amplification methods; It is increasingly difficult for physicians to keep up with the increasing burden of knowledge regarding the genetic aspects of these antigens. Concrete benefits of this gene complex, which has been investigated in various fields and preserves its mystery, have not been determined in liver transplant patients. However, there are publications showing its connection with the bile epithelium in liver transplantation and its relationship with the disappearing bile duct syndrome. In this study, our aim is to explain whether the bile duct complications, which appear like a continuous wall and can lead to frightening pictures, are related to HLA tissue compatibility.
- Conditions
- Liver Transplant; Complications, HLA Antigens
- Being tested
- HLA antigen results
- Keywords
- Liver Transplant, Complications, HLA, biliary fistula, biliary stricture
- Medical subject headings
- Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA antigen resultsOther
HLA-A, HLA-B, HLA-DR tissue matching results in both groups will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Patients with biliary complications | patients with postoperative biliary fistula, biliary stenosis Receives: Other: HLA antigen results | |
| Patients without biliary complications | patients without postoperative biliary fistula and biliary stenosis Receives: Other: HLA antigen results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bliary complications
Biliary fistüla, biliary stenosis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start10 May 2017
- Primary completion10 May 2019
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies 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
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Gündoğan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885582
- Sponsor's protocol ID
- 2017/133
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between HLA Tissue Compatibility and Biliary Complications in Patients With Liver Transplantation
- ClinicalTrials.gov ID
- NCT04885582
- Acronym / sponsor ID
- 2017/133
- Conditions
- Liver Transplant; Complications, HLA Antigens
- Keywords
- Liver Transplant, Complications, HLA, biliary fistula, biliary stricture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 13 May 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.
Liver transplantation has become the accepted treatment option for advanced liver failure in recent years. In addition to the increase in the number of centers performing transplant and the decrease in complication rates depending on the experience gained, the most common biliary complications did not improve at the desired level. For this reason, studies in this field are frequent today.
The structural complexities of HLA antigens have been the subject of investigation in recent years. With the development of DNA and RNA amplification methods; It is increasingly difficult for physicians to keep up with the increasing burden of knowledge regarding the genetic aspects of these antigens. Concrete benefits of this gene complex, which has been investigated in various fields and preserves its mystery, have not been determined in liver transplant patients. However, there are publications showing its connection with the bile epithelium in liver transplantation and its relationship with the disappearing bile duct syndrome. In this study, our aim is to explain whether the bile duct complications, which appear like a continuous wall and can lead to frightening pictures, are related to HLA tissue compatibility.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with biliary complications | – | Other: HLA antigen resultspatients with postoperative biliary fistula, biliary stenosis |
| Patients without biliary complications | – | Other: HLA antigen resultspatients without postoperative biliary fistula and biliary stenosis |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had liver transplantation and HLA tissue tests between 2017 and 2019 at Inonu University liver transplant institute
Key inclusion criteria (1 listed)
- patients with liver transplantation and tested for HLA antigen (recipient - donor)
Key exclusion criteria (1 listed)
- patients who died early Patients whose HLA antigen is not checked
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 |
|---|---|---|
| HLA antigen resultsHLA-A, HLA-B, HLA-DR tissue matching results in both groups will be compared. | Other | Patients with biliary complications, Patients without biliary complications |
Primary outcome
Bliary complications
Time frame: 2 years
Biliary fistüla, biliary stenosis
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 13 May 2021.
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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.
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 Liver Transplant; Complications and HLA Antigens, run by Inonu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 13 May 2021. 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 Turkey (Türkiye). 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?
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?
Bliary complications (time frame: 2 years). 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 13 May 2021.