Alcoholic Liver DiseasesBANDEDNCT01701687
Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease
An observational study of Alcoholic Liver Diseases and Decompensated Cirrhosis, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an inert dye which is purely extracted from the blood by liver cells, and is hence an excellent marker of both liver cell function and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcoholic Liver Diseases, Decompensated Cirrhosis
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Jul 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potentially eligible patients are adult patients with decompensated liver disease with alcohol as a major co-factor, and acutely admitted secondary to sequelae of hepatic decompensation. 100 patients will be recruited for baseline visit over an 30 month study enrolment period, with a 6 month follow up period for all patients.
Who may be able to join
- Male or female patients 18-75 years of age
- Diagnosis of cirrhosis based upon:
- a) Histological confirmation
- b) Combination of clinical and radiological criteria
- c) Validated non invasive biomarker
- Alcohol as the primary aetiology for liver cirrhosis
- Hospital admission related to decompensated liver disease (e.g. ascites, varices, sepsis, alcoholic hepatitis)
- Active alcohol drinking prior to index hospital admission
Who cannot join
- Grade 3 or 4 hepatic encephalopathy
- Hepatocellular carcinoma
- Active non hepatic malignancy
- Known complete portal vein thrombosis
- Alcohol abstinence at time of index hospital admission
- Pregnancy
- Active cardiac devices (e.g. cardiac pacemaker, implantable cardioverter defibrillator)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Notts, NG7 2UH
About this study
Official title: The Feasibility of Liver Biomarkers as Prognostic Markers in Decompensated Alcoholic Liver Disease
Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an inert dye which is purely extracted from the blood by liver cells, and is hence an excellent marker of both liver cell function and overall liver blood flow. There is little data for either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to establish the accuracy of these liver biomarkers in predicting important liver related outcomes (death, transplantation and hospital readmission with cirrhosis related consequences) in patients with severe (decompensated) alcoholic liver disease. Moreover, we will assess whether the serial measurement of biomarkers has any impact on alcohol abstinence, motivation or quality of life. Over an 18 month period, 125 consecutive hospital inpatients with decompensated alcoholic liver disease will undergo baseline biomarker measurement, routine blood and urine tests and qualitative questionnaires. These will be measured during their initial hospital admission (0 months) with subsequent repeat measurement during follow up visits at 1, 2, 4 and 6 months. Each study visit time will be in the region of 30-40 minutes to complete these investigations. The end of the study for individual patients will be patient death, liver transplantation or 6 month from study enrolment; whichever occurs first.
Read the detailed description
This is a single centre longitudinal cohort feasibility pilot study of patients with decompensated alcoholic liver disease. We aim to recruit 125 consecutive patients with decompensated alcoholic liver disease over an 18 month period. This number is based upon approximately 10 admissions per month to acute liver services with decompensated alcoholic liver disease and includes a presumed 20% dropout rate during follow up, giving a total cohort of 100 patients. Patients will undergo a maximum of 6 months follow up following study recruitment.
The purposes of this study are:
- To assess the performance of diagnostic liver biomarkers (Indocyanine Green, Fibroscan and blood and urinary biomarkers) in predicting mortality in decompensated alcoholic liver disease.
- To compare the diagnostic and prognostic end points of these biomarkers with existing cirrhosis prognostic scoring systems (Child Pugh, MELD and UKELD).
- To assess the performance of diagnostic biomarkers as a therapeutic aid to quality of life and alcohol abstinence.
Potentially eligible patients i.e. adults with decompensated liver disease with alcohol as a major co-factor, and acutely admitted secondary to sequelae of hepatic decompensation, will be approached by an existing member of their clinical care team (The CI \& Co-Investigators form part of this team). Any patient who decides to take part in the study will have a baseline inpatient study visit either on their inpatient ward or to the NDDC Biomedical Research Unit (BRU). Subsequent follow up visits will be to the BRU.
Inclusion Criteria:
- Male or female patients 18-75 years of age
- Diagnosis of cirrhosis based upon:
- a) Histological confirmation
- b) Combination of clinical and radiological criteria
- c) Validated non invasive biomarker
- Alcohol as the primary aetiology for liver cirrhosis
- Hospital admission related to decompensated liver disease (e.g. ascites, varices, sepsis, alcoholic hepatitis)
- Active alcohol drinking prior to index hospital admission
Exclusion Criteria:
- Grade 3 or 4 hepatic encephalopathy
- Hepatocellular carcinoma
- Active non hepatic malignancy
- Known complete portal vein thrombosis
- Alcohol abstinence at time of index hospital admission
- Pregnancy
- Active cardiac devices
The research visit will require measurement of ICG clearance, Fibroscan, blood tests, urine tests and questionnaires. They will then be required to attend study visits at 1, 2, 4 and 6 months following the baseline study visit, after which study follow up will cease.
Patients will undergo study visits at the following intervals:
- Baseline visit (study visit 0)
- 1 month (study visit 1)
- 2 months (study visit 2)
- 4 months (study visit 3)
- 6 months (study visit 4)
The following data will be collected for the purposes of this research project at the baseline and subsequent study visits:
- Collection of demography, anthropometry, drug history, smoking, alcohol intake, blood pressure, full blood count, renal function, liver function, coagulation and serum samples
- Brief abdominal examination to detect presence of moderate to severe ascites (for the purposes of Child Pugh score measurement)
- ICG analysis
- Transient elastography (Fibroscan)
- Blood and urinary biomarkers (proteomics and metabonomics)
- Chronic Liver Disease Quality of Life Questionnaire
- Alcohol intake assessments (28 Day AUDIT tool)
- Alcohol STAR tool for qualitative assessment (to assess the influence of Fibroscan/ICG readings on motivation, beliefs and alcohol abstinence)
Demography and history are taken as part of normal clinical care. All patients will be offered standard follow up from both outpatient hepatology clinic and hospital alcohol liaison services throughout the period of study.
- Conditions
- Alcoholic Liver Diseases, Decompensated Cirrhosis
- Keywords
- Cirrhosis, Alcoholic liver disease, Decompensated liver cirrhosis, Hazardous alcohol
- Medical subject headings
- Liver Diseases, Alcoholic, Fibrosis
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 |
|---|---|---|
| Decompensated Alcoholic Cirrhosis | Recruited patients will have diagnosed liver cirrhosis (histological, radiological or accepted clinical parameters)admitted with an episode of decompensation. Patients must still be drinking hazardous alcohol quantities (>14 units for women, >21 units for men) at study enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Related Death
The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis
Measured: 6 months
Secondary outcomes (3)
Non-Liver related death
Mortality unrelated to liver disease up to 6 months from baseline study visit
Measured: 6 months
Hospital Readmission
Hospital readmission secondary to complications of cirrhosis
Measured: 6 months
Alcohol abstinence
Proportion of patients abstinent from alcohol at the 6 month timepoint
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Neil Guha, MRCP, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701687
- Sponsor's protocol ID
- 12050
- Acronym
- BANDED
- Status last verified
- Jul 2015
- First submitted
- 3 Oct 2012
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Liver Biomarkers as Prognostic Markers in Decompensated Alcoholic Liver Disease
- ClinicalTrials.gov ID
- NCT01701687
- Acronym / sponsor ID
- BANDED / 12050
- Conditions
- Alcoholic Liver Diseases, Decompensated Cirrhosis
- Keywords
- Cirrhosis, Alcoholic liver disease, Decompensated liver cirrhosis, Hazardous alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Oct 2012 (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.
Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an inert dye which is purely extracted from the blood by liver cells, and is hence an excellent marker of both liver cell function and overall liver blood flow. There is little data for either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to establish the accuracy of these liver biomarkers in predicting important liver related outcomes (death, transplantation and hospital readmission with cirrhosis related consequences) in patients with severe (decompensated) alcoholic liver disease. Moreover, we will assess whether the serial measurement of biomarkers has any impact on alcohol abstinence, motivation or quality of life. Over an 18 month period, 125 consecutive hospital inpatients with decompensated alcoholic liver disease will undergo baseline biomarker measurement, routine blood and urine tests and qualitative questionnaires. These will be measured during their initial hospital admission (0 months) with subsequent repeat measurement during follow up visits at 1, 2, 4 and 6 months. Each study visit time will be in the region of 30-40 minutes to complete these investigations. The end of the study for individual patients will be patient death, liver transplantation or 6 month from study enrolment; whichever occurs first.
Detailed description
This is a single centre longitudinal cohort feasibility pilot study of patients with decompensated alcoholic liver disease. We aim to recruit 125 consecutive patients with decompensated alcoholic liver disease over an 18 month period. This number is based upon approximately 10 admissions per month to acute liver services with decompensated alcoholic liver disease and includes a presumed 20% dropout rate during follow up, giving a total cohort of 100 patients. Patients will undergo a maximum of 6 months follow up following study recruitment.
The purposes of this study are:
- To assess the performance of diagnostic liver biomarkers (Indocyanine Green, Fibroscan and blood and urinary biomarkers) in predicting mortality in decompensated alcoholic liver disease.
- To compare the diagnostic and prognostic end points of these biomarkers with existing cirrhosis prognostic scoring systems (Child Pugh, MELD and UKELD).
- To assess the performance of diagnostic biomarkers as a therapeutic aid to quality of life and alcohol abstinence.
Potentially eligible patients i.e. adults with decompensated liver disease with alcohol as a major co-factor, and acutely admitted secondary to sequelae of hepatic decompensation, will be approached by an existing member of their clinical care team (The CI \& Co-Investigators form part of this team). Any patient who decides to take part in the study will have a baseline inpatient study visit either on their inpatient ward or to the NDDC Biomedical Research Unit (BRU). Subsequent follow up visits will be to the BRU.
Inclusion Criteria:
- Male or female patients 18-75 years of age
- Diagnosis of cirrhosis based upon:
- a) Histological confirmation
- b) Combination of clinical and radiological criteria
- c) Validated non invasive biomarker
- Alcohol as the primary aetiology for liver cirrhosis
- Hospital admission related to decompensated liver disease (e.g. ascites, varices, sepsis, alcoholic hepatitis)
- Active alcohol drinking prior to index hospital admission
Exclusion Criteria:
- Grade 3 or 4 hepatic encephalopathy
- Hepatocellular carcinoma
- Active non hepatic malignancy
- Known complete portal vein thrombosis
- Alcohol abstinence at time of index hospital admission
- Pregnancy
- Active cardiac devices
The research visit will require measurement of ICG clearance, Fibroscan, blood tests, urine tests and questionnaires. They will then be required to attend study visits at 1, 2, 4 and 6 months following the baseline study visit, after which study follow up will cease.
Patients will undergo study visits at the following intervals:
- Baseline visit (study visit 0)
- 1 month (study visit 1)
- 2 months (study visit 2)
- 4 months (study visit 3)
- 6 months (study visit 4)
The following data will be collected for the purposes of this research project at the baseline and subsequent study visits:
- Collection of demography, anthropometry, drug history, smoking, alcohol intake, blood pressure, full blood count, renal function, liver function, coagulation and serum samples
- Brief abdominal examination to detect presence of moderate to severe ascites (for the purposes of Child Pugh score measurement)
- ICG analysis
- Transient elastography (Fibroscan)
- Blood and urinary biomarkers (proteomics and metabonomics)
- Chronic Liver Disease Quality of Life Questionnaire
- Alcohol intake assessments (28 Day AUDIT tool)
- Alcohol STAR tool for qualitative assessment (to assess the influence of Fibroscan/ICG readings on motivation, beliefs and alcohol abstinence)
Demography and history are taken as part of normal clinical care. All patients will be offered standard follow up from both outpatient hepatology clinic and hospital alcohol liaison services throughout the period of study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decompensated Alcoholic Cirrhosis | – | –Recruited patients will have diagnosed liver cirrhosis (histological, radiological or accepted clinical parameters)admitted with an episode of decompensation. Patients must still be drinking hazardous alcohol quantities (>14 units for women, >21 units for men) at study enrollment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potentially eligible patients are adult patients with decompensated liver disease with alcohol as a major co-factor, and acutely admitted secondary to sequelae of hepatic decompensation. 100 patients will be recruited for baseline visit over an 30 month study enrolment period, with a 6 month follow up period for all patients.
Key inclusion criteria (8 listed)
- Male or female patients 18-75 years of age
- Diagnosis of cirrhosis based upon:
- Alcohol as the primary aetiology for liver cirrhosis
- Hospital admission related to decompensated liver disease (e.g. ascites, varices, sepsis, alcoholic hepatitis)
- Active alcohol drinking prior to index hospital admission
Key exclusion criteria (7 listed)
- Grade 3 or 4 hepatic encephalopathy
- Hepatocellular carcinoma
- Active non hepatic malignancy
- Known complete portal vein thrombosis
- Alcohol abstinence at time of index hospital admission
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
Liver Related Death
Time frame: 6 months
The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis
3 secondary outcomes
Non-Liver related death
Time frame: 6 months
Hospital Readmission
Time frame: 6 months
Alcohol abstinence
Time frame: 6 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 3 Aug 2015.
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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.
Neil Guha, MRCP, PhD principal investigator
University of Nottingham
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 Alcoholic Liver Diseases and Decompensated Cirrhosis, run by University of Nottingham 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 8 inclusion and 7 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 3 Aug 2015. 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?
Liver Related Death (time frame: 6 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 3 Aug 2015.