Evaluating quality of life in patients with chronic liver disease undergoing TIPS
Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt (TIPS) - Pilot Observational Cross-sectional Study
This study looks at how getting a special procedure called TIPS affects the quality of life for people with serious liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05204251 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life in patients with advanced chronic liver disease who have been referred for a Transjugular Intrahepatic Portosystemic Shunt (TIPS). The study will utilize a validated quality of life questionnaire, the SF-36, to gather data on the patients' experiences post-TIPS placement. It focuses on understanding how the procedure affects patients' health and well-being, particularly in relation to complications like portal hypertension. The study will include patients referred to the TIPS service at the University Hospitals of Strasbourg from January 2012 to October 2020.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been referred for TIPS and consented to participate in the study.
Not a fit: Patients who are critically ill, have undergone liver transplantation after TIPS, or are unable to understand the questionnaire may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the impact of TIPS on the quality of life for patients with chronic liver disease.
How similar studies have performed: While few studies have evaluated quality of life in this context, the use of validated questionnaires like the SF-36 is a recognized approach, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Strasbourg
- Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.