Alcoholic CirrhosisPROLIVNCT03508388
Value on Survival of Liver Volume After an Acute Decompensation of an Alcoholic Cirrhosis
An observational study of Alcoholic Cirrhosis and Alcoholic Liver Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Cirrhosis, Alcoholic Liver Disease
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2018to 11 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients suffering from alcoholic cirrhosis, withdrawn or not, hospitalised for an acute decompensation
Who may be able to join
- Adult patients
- Patient suffering from alcoholic cirrhosis (withdrawn or not)
- Patient admitted in emergency for an alcoholic cirrhosis decompensation only
- Prescription for a cutting imaging (CT scan or MRI) during hospitalisation
- Alcohol consumption of more than 3 units per day for men and 2 units for women in average, over at least the last 5 years before the cirrhosis diagnosis
- Patient suffering from decompensated cirrhosis defined by at least one of the following criteria : Model For End-Stage Liver Disease (MELD) score above or equal to 15, ascites needing iterative punctures, symptomatic bacterial ou fungal infections, acute digestive bleeding due to portal hypertension, hepatic encephalopathy defined by a West Haven score above or equal to 2
Who cannot join
- Nodule with typical criteria of hepatocellular carcinoma
- B or C viral infections actives
- Presence of transjugular intrahepatic portosystemic shunt (TIPS)
- Presence of an occlusive thrombosis of the porta or one of the principal branches
- Presence of a thrombosis of the sus-hepatic vein
- Active extra-hepatic malignant tumor
- Decompensated cardio-vascular disease
- Patient unwilling to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Liver Volume on Acute Decompensation of Alcoholic Cirrhosis, a Prospective Multicenter Observational Study
Investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). Our hypothesis is that patients with a "small" liver have a lower survival compared to patients having a "normal" sized liver.
Read the detailed description
In this observational, prospective and multicentre clinical trial, investigator seek to determine the prognostic value of liver volume during an acute decompensation. Investigator plan to enroll admitted adult patients with acute decompensation of an alcoholic cirrhosis (abstinent or not), followed for one year or until death or liver transplantation. Liver volume will be evaluated using CT-scan or MRI reconstructions.
- Conditions
- Alcoholic Cirrhosis, Alcoholic Liver Disease
- Keywords
- Liver volume, Alcoholic cirrhosis, Liver transplantation
- Medical subject headings
- Liver Cirrhosis, Alcoholic, Liver Diseases, Alcoholic
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality or liver transplantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start25 Apr 2018
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Why it stopped: inclusion number not sufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Nīmes, Narbonne Hospital
- Responsible party
- Sponsor
- Investigators
- Jose URSIC BEDOYA, MD, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508388
- Sponsor's protocol ID
- RECHMPL18_0022
- Acronym
- PROLIV
- Status last verified
- Jan 2020
- First submitted
- 23 Apr 2018
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Liver Volume on Acute Decompensation of Alcoholic Cirrhosis, a Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT03508388
- Acronym / sponsor ID
- PROLIV / RECHMPL18_0022
- Conditions
- Alcoholic Cirrhosis, Alcoholic Liver Disease
- Keywords
- Liver volume, Alcoholic cirrhosis, Liver transplantation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inclusion number not sufficient
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Nīmes, Narbonne Hospital
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 25 Apr 2018 (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.
Investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). Our hypothesis is that patients with a "small" liver have a lower survival compared to patients having a "normal" sized liver.
Detailed description
In this observational, prospective and multicentre clinical trial, investigator seek to determine the prognostic value of liver volume during an acute decompensation. Investigator plan to enroll admitted adult patients with acute decompensation of an alcoholic cirrhosis (abstinent or not), followed for one year or until death or liver transplantation. Liver volume will be evaluated using CT-scan or MRI reconstructions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients suffering from alcoholic cirrhosis, withdrawn or not, hospitalised for an acute decompensation
Key inclusion criteria (6 listed)
- Adult patients
- Patient suffering from alcoholic cirrhosis (withdrawn or not)
- Patient admitted in emergency for an alcoholic cirrhosis decompensation only
- Prescription for a cutting imaging (CT scan or MRI) during hospitalisation
- Alcohol consumption of more than 3 units per day for men and 2 units for women in average, over at least the last 5 years before the cirrhosis diagnosis
Key exclusion criteria (8 listed)
- Nodule with typical criteria of hepatocellular carcinoma
- B or C viral infections actives
- Presence of transjugular intrahepatic portosystemic shunt (TIPS)
- Presence of an occlusive thrombosis of the porta or one of the principal branches
- Presence of a thrombosis of the sus-hepatic vein
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
All cause mortality or liver transplantation
Time frame: 1 year
Results and safety
The study was stopped early (reason given: inclusion number not sufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Jose URSIC BEDOYA, MD principal investigator
UH Montpellier
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 Cirrhosis and Alcoholic Liver Disease, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 19 Dec 2022. 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 France. 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 was stopped early (reason given: inclusion number not sufficient). Results are not available in the source record.
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?
All cause mortality or liver transplantation (time frame: 1 year). 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 19 Dec 2022.