Liver FailureNCT02307890
The Relationship of Initial Liver Profile and Outcome After Transplantation
An observational study of Liver Failure, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one or more bile ducts probably caused by inadequate blood flow or a failure of biliary epithelium to regenerate. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Liver Failure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2014to 1 Dec 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Liver transplantation group
Who may be able to join
- All deceased adult liver transplant donors (>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh
Who cannot join
- Paediatric liver transplant donors (<16 years of age).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
About this study
Official title: The Relationship of Hepatobiliary microRNA Expression Profile and Clinical Outcome in Liver Transplantation
Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one or more bile ducts probably caused by inadequate blood flow or a failure of biliary epithelium to regenerate. It typically presents weeks to months after liver transplantation, is often refractory to treatment and can result in a requirement for re-transplantation. Although IC is more common following DCD liver transplantation, it is otherwise very difficult to predict and the underlying pathogenesis is poorly understood. The aim of this study is to correlate microRNA (miRNA) levels and markers of senescence in liver and bile duct biopsies taken during liver transplantation with the incidence of IC following liver transplantation.
Read the detailed description
Study population
Tissue from all deceased adult liver transplant grafts will be collected. The test samples will be selected from procedures were the liver transplant recipient has developed IC. The control samples will include tissues from procedures were the transplant recipient had an uncomplicated outcome. There will be matching of test samples and control samples based on a range of clinical factors.
Consent
Standard consent for organ donation documentation has a general consent to research section. Due to the small risk of damage to blood vessels when taking samples the liver transplant recipient will also be consented for these procedures to take place.
Tissue sampling
Liver and bile duct samples from each graft will be obtained at various different time points during liver transplant procedures.
Processing of specimens
Following removal of the specimens, samples will be divided then added to RNAlater (Life Technologies, Paisley, UK), 10% formaldehyde or will be snap frozen. At a later time point samples will be analysed.
Definition of ischemic cholangiopathy
IC will be defined as strictures, dilatations, or irregularities of the intra- or extrahepatic bile ducts of the liver graft. Isolated strictures at the bile duct anastomosis will be excluded. The diagnosis will be based on at least one adequate imaging study of the biliary tree, after exclusion of hepatic artery thrombosis by Doppler ultrasound, computed tomography or conventional angiography.
- Conditions
- Liver Failure
- Keywords
- Liver Transplantation
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation group | Participants will include all deceased adult liver transplant donors (>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh. Exclusion criteria will include paediatric liver transplant donors (<16 years of age). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hepatobiliary miRNA expression during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation
Assessed by sequencing of liver and bile duct samples taken during different stages of liver transplantation and correlation with clinical outcomes
Measured: 12 months
Secondary outcomes (1)
Changes in hepatobiliary senescence during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation
Assessed by senescence markers in liver and bile duct samples taken during different stages of liver transplantation and correlation with clinical outcomes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study start6 Aug 2014
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Ewen Harrison, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307890
- Sponsor's protocol ID
- 2014/097
- Status last verified
- May 2024
- First submitted
- 24 Nov 2014
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
O'Neill S, Roebuck A, Khoo E, Wigmore SJ, Harrison EM. A meta-analysis and meta-regression of outcomes including biliary complications in donation after cardiac death liver transplantation. Transpl Int. 2014 Nov;27(11):1159-74. doi: 10.1111/tri.12403.
PubMed 25052036
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Hepatobiliary microRNA Expression Profile and Clinical Outcome in Liver Transplantation
- ClinicalTrials.gov ID
- NCT02307890
- Acronym / sponsor ID
- 2014/097
- Conditions
- Liver Failure
- Keywords
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 6 Aug 2014 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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.
Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one or more bile ducts probably caused by inadequate blood flow or a failure of biliary epithelium to regenerate. It typically presents weeks to months after liver transplantation, is often refractory to treatment and can result in a requirement for re-transplantation. Although IC is more common following DCD liver transplantation, it is otherwise very difficult to predict and the underlying pathogenesis is poorly understood. The aim of this study is to correlate microRNA (miRNA) levels and markers of senescence in liver and bile duct biopsies taken during liver transplantation with the incidence of IC following liver transplantation.
Detailed description
Study population
Tissue from all deceased adult liver transplant grafts will be collected. The test samples will be selected from procedures were the liver transplant recipient has developed IC. The control samples will include tissues from procedures were the transplant recipient had an uncomplicated outcome. There will be matching of test samples and control samples based on a range of clinical factors.
Consent
Standard consent for organ donation documentation has a general consent to research section. Due to the small risk of damage to blood vessels when taking samples the liver transplant recipient will also be consented for these procedures to take place.
Tissue sampling
Liver and bile duct samples from each graft will be obtained at various different time points during liver transplant procedures.
Processing of specimens
Following removal of the specimens, samples will be divided then added to RNAlater (Life Technologies, Paisley, UK), 10% formaldehyde or will be snap frozen. At a later time point samples will be analysed.
Definition of ischemic cholangiopathy
IC will be defined as strictures, dilatations, or irregularities of the intra- or extrahepatic bile ducts of the liver graft. Isolated strictures at the bile duct anastomosis will be excluded. The diagnosis will be based on at least one adequate imaging study of the biliary tree, after exclusion of hepatic artery thrombosis by Doppler ultrasound, computed tomography or conventional angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation group | – | –Participants will include all deceased adult liver transplant donors (>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh. Exclusion criteria will include paediatric liver transplant donors (<16 years of age). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Liver transplantation group
Key inclusion criteria (1 listed)
- All deceased adult liver transplant donors (>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh
Key exclusion criteria (1 listed)
- Paediatric liver transplant donors (<16 years of age).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in hepatobiliary miRNA expression during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation
Time frame: 12 months
Assessed by sequencing of liver and bile duct samples taken during different stages of liver transplantation and correlation with clinical outcomes
1 secondary outcome
Changes in hepatobiliary senescence during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation
Time frame: 12 months
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 19 Sep 2024.
- Background: PubMed 25052036O'Neill S, Roebuck A, Khoo E, Wigmore SJ, Harrison EM. A meta-analysis and meta-regression of outcomes including biliary complications in donation after cardiac death liver transplantation. Transpl Int. 2014 Nov;27(11):1159-74. doi: 10.1111/tri.12403.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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.
Ewen Harrison principal investigator
University of Edinburgh
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 Failure, run by University of Edinburgh at 1 site in United Kingdom.
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 19 Sep 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 United Kingdom. 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?
Changes in hepatobiliary miRNA expression during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307890, which also lists 1 linked publication.
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 19 Sep 2024.