Chronic Liver DiseaseTIPSNCT05204251
Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt
An observational study of Chronic Liver Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patient with Advanced Chronic Liver Disease often present portal hypertension which may lead to bleading or ascites. One of the treatment of portal hypertension in these patients is the placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2022to Apr 2024
- 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: Patient with Advanced Chronic Liver Disease who underwent a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement at the University Hospital of Strasbourg
Who may be able to join
- Age ≥ 18 years
- Patients referred to the TIPS service between January 2012 and October 2020 at the University Hospitals of Strasbourg, with a follow-up period of at least 1 month
- Subjects who have not expressed any opposition to the use of their medical data for research purposes
- For subjects invited to fill in the questionnaires: subject having expressed his/her agreement with the use of his/her medical data in the framework of the current study
Who cannot join
- Diseased patient
- Liver transplant patient following TIPS
- Pregnancy
- Patient in a vulnerable situation
- Patient under court protection, guardianship or trusteeship
- Difficulties in understanding the questionnaire
- Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- Subject under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France
Strasbourg, 6720
Pierre DE MARINI, +33 3.88.12.71.43, pierre.demarini@chru-strasbourg.fr
Pierre DE MARINI
About this study
Official title: Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt (TIPS) - Pilot Observational Cross-sectional Study
Patient with Advanced Chronic Liver Disease often present portal hypertension which may lead to bleading or ascites.
One of the treatment of portal hypertension in these patients is the placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).
Read more
The indications for placing TIPS take on various clinical presentations, the most classic being digestive haemorrhage by rupture of oesophageal and/or gastric varices and refractory ascites.
TIPS placement involves changes in haemodynamics and liver function that may alter the patients' condition and quality of life.
Very few articles have evaluated the quality of life of these patients and when quality of life is evaluated it is mostly with not adapted or not validated scales.
The main objective of this study is to evaluate the quality of life of patients who have undergone TIPS using a validated and standardised quality of life questionnaire (the SF-36 questionnaire).
- Conditions
- Chronic Liver Disease
- Being tested
- Questionnaire
- Keywords
- Chronic liver disease, TIPS, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Quality of Life assessed with the SF-36 questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental component of quality of Life of the
Assessment of the mental component of quality of life by a generic questionnaire (SF-36),
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start11 Apr 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204251
- Sponsor's protocol ID
- 8338
- Acronym
- TIPS
- Status last verified
- Oct 2023
- First submitted
- 10 Jan 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt (TIPS) - Pilot Observational Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05204251
- Acronym / sponsor ID
- TIPS / 8338
- Conditions
- Chronic Liver Disease
- Keywords
- Chronic liver disease, TIPS, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 24 Jan 2022 (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.
Patient with Advanced Chronic Liver Disease often present portal hypertension which may lead to bleading or ascites.
One of the treatment of portal hypertension in these patients is the placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).
The indications for placing TIPS take on various clinical presentations, the most classic being digestive haemorrhage by rupture of oesophageal and/or gastric varices and refractory ascites.
TIPS placement involves changes in haemodynamics and liver function that may alter the patients' condition and quality of life.
Very few articles have evaluated the quality of life of these patients and when quality of life is evaluated it is mostly with not adapted or not validated scales.
The main objective of this study is to evaluate the quality of life of patients who have undergone TIPS using a validated and standardised quality of life questionnaire (the SF-36 questionnaire).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Advanced Chronic Liver Disease who underwent a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement at the University Hospital of Strasbourg
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients referred to the TIPS service between January 2012 and October 2020 at the University Hospitals of Strasbourg, with a follow-up period of at least 1 month
- Subjects who have not expressed any opposition to the use of their medical data for research purposes
- For subjects invited to fill in the questionnaires: subject having expressed his/her agreement with the use of his/her medical data in the framework of the current study
Key exclusion criteria (8 listed)
- Diseased patient
- Liver transplant patient following TIPS
- Pregnancy
- Patient in a vulnerable situation
- Patient under court protection, guardianship or trusteeship
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 |
|---|---|---|
| QuestionnaireQuality of Life assessed with the SF-36 questionnaire | Behavioural | – |
Primary outcome
Mental component of quality of Life of the
Time frame: 45 minutes
Assessment of the mental component of quality of life by a generic questionnaire (SF-36),
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France
Strasbourg, France
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 Chronic Liver Disease, run by University Hospital, Strasbourg, France 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 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental component of quality of Life of the (time frame: 45 minutes). 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 10 Oct 2023.