Chronic Liver Disease Clinical Trial
— TIPSOfficial title:
Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt (TIPS) - Pilot Observational Cross-sectional Study
| NCT number | NCT05204251 |
| Other study ID # | 8338 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 11, 2022 |
| Est. completion date | April 2024 |
| Verified date | October 2023 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Recruiting |
| Enrollment | 45 |
| Est. completion date | April 2024 |
| Est. primary completion date | April 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mental component of quality of Life of the | Assessment of the mental component of quality of life by a generic questionnaire (SF-36), | 45 minutes |
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