Liver Disease ChronicHEP-UHDNCT06838468
cACLD in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit
An observational study of Liver Disease Chronic and Cirrhosis, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The aim of this study is to conduct a quick assessment of potential liver damage caused by chronic alcohol consumption. Taking advantage of the patient's admission to a specialized detoxification unit, several tests will be performed to determine the extent of liver damage through blood tests, ultrasound, and FibroScan Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Disease Chronic, Cirrhosis, Detoxification
- What is being tested?
- Screening of compensated advance chronic liver disease
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 6 Mar 2024to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients admitted to the detoxification unit for alcohol use disorder or de psychiatry unit for dual pathology with harmful alcohol consumption
Who may be able to join
- Patients admitted to the detoxification unit for alcohol use disorder
- Patients admitted to the psychiatry unit for dual pathology with harmful alcohol consumption (> 30 g/day in men (3 standard drinks) and > 20 g/day in women (2 standard drinks))
Who cannot join
- Refusal to undergo additional tests (blood analysis, ultrasound, and FibroScan)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Detection of Advanced Chronic Liver Disease in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit
The aim of this study is to conduct a quick assessment of potential liver damage caused by chronic alcohol consumption. Taking advantage of the patient's admission to a specialized detoxification unit, several tests will be performed to determine the extent of liver damage through blood tests, ultrasound, and FibroScan
Read the detailed description
There is very little recent data on the prevalence of advance chronic liver disease in high-risk patients, particularly in our region, making studies evaluating this necessary.
In the European clinical practice guidelines (EASL Clinical Practice Guidelines: Management of Alcohol-Related Liver Disease), it is recommended to screen for advance chronic liver disease in high-risk populations such as patients in rehabilitation and detox clinics and heavy drinkers. advance chronic liver disease should be considered in patients presenting with extrahepatic manifestations of alcohol use disorder, such as peripheral symmetric neuropathy, pancreatitis, and cardiomyopathy, among others.
Screening for liver disease in high-risk groups should not only include liver function tests (e.g., gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], or aspartate aminotransferase [AST]) but also include testing for liver fibrosis (e.g., transient elastography such as FibroScan®), given that advanced liver disease may occur in patients with normal liver profiles.
If any abnormalities are detected in liver profiles or elastography, an abdominal ultrasound should be performed to rule out hepatocellular carcinoma and a complete liver disease study should be carried out to exclude alternative or additional causes of liver damage. Current clinical guidelines (Spanish, European, and American) do not specify which tools to use in each risk subgroup.
The primary objective is to assess the prevalence of advance chronic liver disease measured by transient elastography in patients admitted to the Hospital Detoxification Unit and the acute psychiatric unit with dual pathology and harmful alcohol consumption.
This is a prospective, descriptive, single-center study conducted at Hospital Parc Taulí in Sabadell on patients admitted to the Hospital Detoxification Unit and the psychiatric unit with a diagnosis of dual pathology and harmful alcohol consumption. The study duration will be one year (from June 2024 to June 2025).
We will obtein clinical Variables like date of birth, sex, ethnicity, height, height, medical history (e.g., diagnosis of diabetes, dyslipidemia, hypertension, or underlying psychiatric disorder); Laboratory Variables: ALT, AST, alkaline phosphatase (ALP), GGT, total bilirubin, INR, platelets, glucose, HbA1c, total cholesterol, HDL, LDL, TSH, ferritin, and transferrin saturation. For patients with abnormal liver profiles, a second etiological study will be performed, including ceruloplasmin, copper, alpha-1 antitrypsin, ANA and SLA autoantibodies, immunoglobulins (IgA, IgG, IgM), and protein electrophoresis.
Elastography Variables: FibroScan® values and CAP (Control Attenuation Parameter) to estimate liver stiffness and quantify hepatic fat, respectively.
Radiological Variables: Abdominal ultrasound findings (e.g., homogeneous or heterogeneous liver, presence of steatosis, nodular liver borders, splenomegaly, recanalization of the paraumbilical vein, collateral circulation, portal velocity, hepatic nodules). Endoscopic Variables: For patients diagnosed with advance chronic liver disease, esophagogastroduodenoscopy will be performed to rule out esophageal varices if criteria are met. Serological Variables for Fibrosis Estimation: LiverRisk score, APRI, FIB-4, Forns index, AAR (AST to ALT ratio).
Regardless of liver profile abnormalities, an abdominal ultrasound will be requested to evaluate parenchymal changes and other indirect signs of liver disease and/or portal hypertension. Additional data collected by psychiatry will include the patient's date of birth, years of alcohol consumption, grams of alcohol/day measured in Standard Drink Units (SDUs), weight, height, relevant cardiovascular diseases (hypertension, diabetes, dyslipidemia), and underlying psychiatric disorders.
A hepatology consultation will be requested, and FibroScan® will be performed during hospitalization. All fibrosis scores (LiverRisk score, APRI, FIB-4, Forns, and AAR) will be calculated using demographic and laboratory data.
If liver profile abnormalities are detected upon admission, a complete second etiological study will be requested.
All patients, regardless of whether they have advanced chronic liver disease or not, will be evaluated by a hepatologist who will provide information about the results of the diagnostic tests performed and the potential harmful effects of alcohol on the liver and overall health. This will reinforce the information provided by the psychiatrist in an effort to encourage the patient to cease alcohol consumption.
If the patient presents advance chronic liver disease (FibroScan® >8 KPa) or analytical, elastographic, or radiological evidence suggestive of cirrhosis will be referred to hepatology outpatient clinics for further evaluation and follow-up. Patients without advance chronic liver disease findings will be referred to primary care by their attending psychiatrist for follow-up.
- Being tested
- Screening of compensated advance chronic liver disease
- Keywords
- chronic advance liver disease, detoxification unit, elastography, liver risk score
- Medical subject headings
- Fibrosis, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening of compensated advance chronic liver diseaseDiagnostic test
The tests performed will include a general blood analysis to evaluate liver and kidney function, an assessment of the prevalence of metabolic diseases such as obesity, hypertension, or diabetes, an abdominal ultrasound, and elastography to assess liver stiffness.
Another intervention to be studied is whether the request for diagnostic tests to evaluate liver disease, as well as the visit of the hepatologist during hospitalization in the detoxification unit, influences subsequent alcohol abstinence. To this end, abstinence will be assessed six months after admission to the alcohol detoxification unit and compared with a retrospective cohort of patients admitted to the detoxification unit one year ago, in whom no liver disease evaluation was conducted neither information of potencial liver damage was offered by hepatologist and the intervention was carried out only by the psychiatrists responsible for the unit.
| Study group | Role | What they receive |
|---|---|---|
| Patients with excessive alcohol consumption admitted to the hospital detoxification unit | The intervention performed on patients who have been electively admitted to the hospital detoxification unit consists of diagnostic tests to assess potential liver damage secondary to alcohol consumption. These are usually young patients with very high alcohol intake who, under normal circumstances, would need to be evaluated on an outpatient basis. Since the potential prevalence of advanced liver disease is expected to be higher in this subgroup of patients, the hospital stay is utilized to carry out all these tests quickly. The tests performed will include a general blood analysis to evaluate liver and kidney function, an assessment of the prevalence of metabolic diseases such as obesity, hypertension, or diabetes, an abdominal ultrasound, and elastography to assess liver stiffness. Receives: Diagnostic Test: Screening of compensated advance chronic liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of advanced chronic liver disease in patients who are electively admitted to the hospital alcohol detoxification unit
Prevalence of pathological findings in the fibroscan that suggest compensated chronic liver disease
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start6 Mar 2024
- Primary completion12 Mar 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver Disease ChronicStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Sanchez-Delgado, Corporacion Parc Tauli
- Investigators
- Jordi Sánchez Delgado, MD. PhD, Principal investigator, Consorci Corporació Sanitària Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838468
- Sponsor's protocol ID
- 2024/5057
- Other IDs
- 2024/5057
- Acronym
- HEP-UHD
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information about the project will be shared if another center is interested in participating and conducting a multicenter study
Publications
Serra-Burriel M, Juanola A, Serra-Burriel F, Thiele M, Graupera I, Pose E, Pera G, Grgurevic I, Caballeria L, Piano S, van Kleef L, Reichert M, Roulot D, Pericas JM, Schattenberg JM, Tsochatztis EA, Guha IN, Garcia-Retortillo M, Hernandez R, Hoyo J, Fuentes M, Exposito C, Martinez A, Such P, Madir A, Detlefsen S, Tonon M, Martini A, Ma AT, Pich J, Bonfill E, Juan M, Soria A, Carol M, Gratacos-Gines J, Morillas RM, Toran P, Navarrete JM, Torrejon A, Fournier C, Llorca A, Arslanow A, de Koning HJ, Cucchietti F, Manns M, Newsome PN, Hernaez R, Allen A, Angeli P, de Knegt RJ, Karlsen TH, Galle P, Wong VW, Fabrellas N, Castera L, Krag A, Lammert F, Kamath PS, Gines P; LiverScreen Consortium Investigators. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study. Lancet. 2023 Sep 16;402(10406):988-996. doi: 10.1016/S0140-6736(23)01174-1. Epub 2023 Aug 9.
PubMed 37572680Crabb DW, Bataller R, Chalasani NP, Kamath PS, Lucey M, Mathurin P, McClain C, McCullough A, Mitchell MC, Morgan TR, Nagy L, Radaeva S, Sanyal A, Shah V, Szabo G; NIAAA Alcoholic Hepatitis Consortia. Standard Definitions and Common Data Elements for Clinical Trials in Patients With Alcoholic Hepatitis: Recommendation From the NIAAA Alcoholic Hepatitis Consortia. Gastroenterology. 2016 Apr;150(4):785-90. doi: 10.1053/j.gastro.2016.02.042. Epub 2016 Feb 24. No abstract available.
PubMed 26921783European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. J Hepatol. 2018 Jul;69(1):154-181. doi: 10.1016/j.jhep.2018.03.018. Epub 2018 Apr 5. No abstract available.
PubMed 29628280Addolorato G, Mirijello A, Leggio L, Ferrulli A, D'Angelo C, Vassallo G, Cossari A, Gasbarrini G, Landolfi R, Agnes S, Gasbarrini A; Gemelli OLT Group. Liver transplantation in alcoholic patients: impact of an alcohol addiction unit within a liver transplant center. Alcohol Clin Exp Res. 2013 Sep;37(9):1601-8. doi: 10.1111/acer.12117. Epub 2013 Apr 11.
PubMed 23578009Askgaard G, Leon DA, Kjaer MS, Deleuran T, Gerds TA, Tolstrup JS. Risk for alcoholic liver cirrhosis after an initial hospital contact with alcohol problems: A nationwide prospective cohort study. Hepatology. 2017 Mar;65(3):929-937. doi: 10.1002/hep.28943. Epub 2017 Jan 6.
PubMed 27862159Rehm J, Taylor B, Mohapatra S, Irving H, Baliunas D, Patra J, Roerecke M. Alcohol as a risk factor for liver cirrhosis: a systematic review and meta-analysis. Drug Alcohol Rev. 2010 Jul;29(4):437-45. doi: 10.1111/j.1465-3362.2009.00153.x.
PubMed 20636661Gines P, Krag A, Abraldes JG, Sola E, Fabrellas N, Kamath PS. Liver cirrhosis. Lancet. 2021 Oct 9;398(10308):1359-1376. doi: 10.1016/S0140-6736(21)01374-X. Epub 2021 Sep 17.
PubMed 34543610Passi S, Rothschild-Boros MC, Fasella P, Nazzaro-Porro M, Whitehouse D. An application of high performance liquid chromatography to analysis of lipids in archaeological samples. J Lipid Res. 1981 Jul;22(5):778-84.
PubMed 7026710
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Advanced Chronic Liver Disease in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit
- ClinicalTrials.gov ID
- NCT06838468
- Acronym / sponsor ID
- HEP-UHD / 2024/5057
- Keywords
- chronic advance liver disease, detoxification unit, elastography, liver risk score
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2025 (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.
The aim of this study is to conduct a quick assessment of potential liver damage caused by chronic alcohol consumption. Taking advantage of the patient's admission to a specialized detoxification unit, several tests will be performed to determine the extent of liver damage through blood tests, ultrasound, and FibroScan
Detailed description
There is very little recent data on the prevalence of advance chronic liver disease in high-risk patients, particularly in our region, making studies evaluating this necessary.
In the European clinical practice guidelines (EASL Clinical Practice Guidelines: Management of Alcohol-Related Liver Disease), it is recommended to screen for advance chronic liver disease in high-risk populations such as patients in rehabilitation and detox clinics and heavy drinkers. advance chronic liver disease should be considered in patients presenting with extrahepatic manifestations of alcohol use disorder, such as peripheral symmetric neuropathy, pancreatitis, and cardiomyopathy, among others.
Screening for liver disease in high-risk groups should not only include liver function tests (e.g., gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], or aspartate aminotransferase [AST]) but also include testing for liver fibrosis (e.g., transient elastography such as FibroScan®), given that advanced liver disease may occur in patients with normal liver profiles.
If any abnormalities are detected in liver profiles or elastography, an abdominal ultrasound should be performed to rule out hepatocellular carcinoma and a complete liver disease study should be carried out to exclude alternative or additional causes of liver damage. Current clinical guidelines (Spanish, European, and American) do not specify which tools to use in each risk subgroup.
The primary objective is to assess the prevalence of advance chronic liver disease measured by transient elastography in patients admitted to the Hospital Detoxification Unit and the acute psychiatric unit with dual pathology and harmful alcohol consumption.
This is a prospective, descriptive, single-center study conducted at Hospital Parc Taulí in Sabadell on patients admitted to the Hospital Detoxification Unit and the psychiatric unit with a diagnosis of dual pathology and harmful alcohol consumption. The study duration will be one year (from June 2024 to June 2025).
We will obtein clinical Variables like date of birth, sex, ethnicity, height, height, medical history (e.g., diagnosis of diabetes, dyslipidemia, hypertension, or underlying psychiatric disorder); Laboratory Variables: ALT, AST, alkaline phosphatase (ALP), GGT, total bilirubin, INR, platelets, glucose, HbA1c, total cholesterol, HDL, LDL, TSH, ferritin, and transferrin saturation. For patients with abnormal liver profiles, a second etiological study will be performed, including ceruloplasmin, copper, alpha-1 antitrypsin, ANA and SLA autoantibodies, immunoglobulins (IgA, IgG, IgM), and protein electrophoresis.
Elastography Variables: FibroScan® values and CAP (Control Attenuation Parameter) to estimate liver stiffness and quantify hepatic fat, respectively.
Radiological Variables: Abdominal ultrasound findings (e.g., homogeneous or heterogeneous liver, presence of steatosis, nodular liver borders, splenomegaly, recanalization of the paraumbilical vein, collateral circulation, portal velocity, hepatic nodules). Endoscopic Variables: For patients diagnosed with advance chronic liver disease, esophagogastroduodenoscopy will be performed to rule out esophageal varices if criteria are met. Serological Variables for Fibrosis Estimation: LiverRisk score, APRI, FIB-4, Forns index, AAR (AST to ALT ratio).
Regardless of liver profile abnormalities, an abdominal ultrasound will be requested to evaluate parenchymal changes and other indirect signs of liver disease and/or portal hypertension. Additional data collected by psychiatry will include the patient's date of birth, years of alcohol consumption, grams of alcohol/day measured in Standard Drink Units (SDUs), weight, height, relevant cardiovascular diseases (hypertension, diabetes, dyslipidemia), and underlying psychiatric disorders.
A hepatology consultation will be requested, and FibroScan® will be performed during hospitalization. All fibrosis scores (LiverRisk score, APRI, FIB-4, Forns, and AAR) will be calculated using demographic and laboratory data.
If liver profile abnormalities are detected upon admission, a complete second etiological study will be requested.
All patients, regardless of whether they have advanced chronic liver disease or not, will be evaluated by a hepatologist who will provide information about the results of the diagnostic tests performed and the potential harmful effects of alcohol on the liver and overall health. This will reinforce the information provided by the psychiatrist in an effort to encourage the patient to cease alcohol consumption.
If the patient presents advance chronic liver disease (FibroScan® >8 KPa) or analytical, elastographic, or radiological evidence suggestive of cirrhosis will be referred to hepatology outpatient clinics for further evaluation and follow-up. Patients without advance chronic liver disease findings will be referred to primary care by their attending psychiatrist for follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with excessive alcohol consumption admitted to the hospital detoxification unit | – | Diagnostic Test: Screening of compensated advance chronic liver diseaseThe intervention performed on patients who have been electively admitted to the hospital detoxification unit consists of diagnostic tests to assess potential liver damage secondary to alcohol consumption. These are usually young patients with very high alcohol intake who, under normal circumstances, would need to be evaluated on an outpatient basis. Since the potential prevalence of advanced liver disease is expected to be higher in this subgroup of patients, the hospital stay is utilized to carry out all these tests quickly. The tests performed will include a general blood analysis to evaluate liver and kidney function, an assessment of the prevalence of metabolic diseases such as obesity, hypertension, or diabetes, an abdominal ultrasound, and elastography to assess liver stiffness. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the detoxification unit for alcohol use disorder or de psychiatry unit for dual pathology with harmful alcohol consumption
Key inclusion criteria (2 listed)
- Patients admitted to the detoxification unit for alcohol use disorder
- Patients admitted to the psychiatry unit for dual pathology with harmful alcohol consumption (> 30 g/day in men (3 standard drinks) and > 20 g/day in women (2 standard drinks))
Key exclusion criteria (1 listed)
- Refusal to undergo additional tests (blood analysis, ultrasound, and FibroScan)
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 |
|---|---|---|
| Screening of compensated advance chronic liver diseaseThe tests performed will include a general blood analysis to evaluate liver and kidney function, an assessment of the prevalence of metabolic diseases such as obesity, hypertension, or diabetes, an abdominal ultrasound, and elastography to assess liver stiffness. Another intervention to be studied is whether the request for diagnostic tests to evaluate liver disease, as well as the visit of the hepatologist during hospitalization in the detoxification unit, influences subsequent alcohol abstinence. To this end, abstinence will be assessed six months after admission to the alcohol detoxification unit and compared with a retrospective cohort of patients admitted to the detoxification unit one year ago, in whom no liver disease evaluation was conducted neither information of potencial liver damage was offered by hepatologist and the intervention was carried out only by the psychiatrists responsible for the unit. | Diagnostic test | Patients with excessive alcohol consumption admitted to the hospital detoxification unit |
Primary outcome
Prevalence of advanced chronic liver disease in patients who are electively admitted to the hospital alcohol detoxification unit
Time frame: 5 days
Prevalence of pathological findings in the fibroscan that suggest compensated chronic liver disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Results publication: PubMed 37572680Serra-Burriel M, Juanola A, Serra-Burriel F, Thiele M, Graupera I, Pose E, Pera G, Grgurevic I, Caballeria L, Piano S, van Kleef L, Reichert M, Roulot D, Pericas JM, Schattenberg JM, Tsochatztis EA, Guha IN, Garcia-Retortillo M, Hernandez R, Hoyo J, Fuentes M, Exposito C, Martinez A, Such P, Madir A, Detlefsen S, Tonon M, Martini A, Ma AT, Pich J, Bonfill E, Juan M, Soria A, Carol M, Gratacos-Gines J, Morillas RM, Toran P, Navarrete JM, Torrejon A, Fournier C, Llorca A, Arslanow A, de Koning HJ, Cucchietti F, Manns M, Newsome PN, Hernaez R, Allen A, Angeli P, de Knegt RJ, Karlsen TH, Galle P, Wong VW, Fabrellas N, Castera L, Krag A, Lammert F, Kamath PS, Gines P; LiverScreen Consortium Investigators. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study. Lancet. 2023 Sep 16;402(10406):988-996. doi: 10.1016/S0140-6736(23)01174-1. Epub 2023 Aug 9.
- Results publication: PubMed 26921783Crabb DW, Bataller R, Chalasani NP, Kamath PS, Lucey M, Mathurin P, McClain C, McCullough A, Mitchell MC, Morgan TR, Nagy L, Radaeva S, Sanyal A, Shah V, Szabo G; NIAAA Alcoholic Hepatitis Consortia. Standard Definitions and Common Data Elements for Clinical Trials in Patients With Alcoholic Hepatitis: Recommendation From the NIAAA Alcoholic Hepatitis Consortia. Gastroenterology. 2016 Apr;150(4):785-90. doi: 10.1053/j.gastro.2016.02.042. Epub 2016 Feb 24. No abstract available.
- Results publication: PubMed 29628280European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. J Hepatol. 2018 Jul;69(1):154-181. doi: 10.1016/j.jhep.2018.03.018. Epub 2018 Apr 5. No abstract available.
- Results publication: PubMed 23578009Addolorato G, Mirijello A, Leggio L, Ferrulli A, D'Angelo C, Vassallo G, Cossari A, Gasbarrini G, Landolfi R, Agnes S, Gasbarrini A; Gemelli OLT Group. Liver transplantation in alcoholic patients: impact of an alcohol addiction unit within a liver transplant center. Alcohol Clin Exp Res. 2013 Sep;37(9):1601-8. doi: 10.1111/acer.12117. Epub 2013 Apr 11.
- Results publication: PubMed 27862159Askgaard G, Leon DA, Kjaer MS, Deleuran T, Gerds TA, Tolstrup JS. Risk for alcoholic liver cirrhosis after an initial hospital contact with alcohol problems: A nationwide prospective cohort study. Hepatology. 2017 Mar;65(3):929-937. doi: 10.1002/hep.28943. Epub 2017 Jan 6.
- Results publication: PubMed 20636661Rehm J, Taylor B, Mohapatra S, Irving H, Baliunas D, Patra J, Roerecke M. Alcohol as a risk factor for liver cirrhosis: a systematic review and meta-analysis. Drug Alcohol Rev. 2010 Jul;29(4):437-45. doi: 10.1111/j.1465-3362.2009.00153.x.
- Results publication: PubMed 34543610Gines P, Krag A, Abraldes JG, Sola E, Fabrellas N, Kamath PS. Liver cirrhosis. Lancet. 2021 Oct 9;398(10308):1359-1376. doi: 10.1016/S0140-6736(21)01374-X. Epub 2021 Sep 17.
- Results publication: PubMed 7026710Passi S, Rothschild-Boros MC, Fasella P, Nazzaro-Porro M, Whitehouse D. An application of high performance liquid chromatography to analysis of lipids in archaeological samples. J Lipid Res. 1981 Jul;22(5):778-84.
- Individual participant dataSharing planned: Yes. Information about the project will be shared if another center is interested in participating and conducting a multicenter study
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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.
Jordi Sánchez Delgado, MD. PhD principal investigator
Consorci Corporació Sanitària Parc Taulí
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 Disease Chronic and Cirrhosis, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 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: enrolling by invitation, as of the sponsor's last update on 20 Feb 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence of advanced chronic liver disease in patients who are electively admitted to the hospital alcohol detoxification unit (time frame: 5 days). 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 NCT06838468, which also lists 8 linked publications.
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 20 Feb 2025.