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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date October 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaire
Quality of Life assessed with the SF-36 questionnaire

Locations

Country Name City State
France Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

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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