Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt

Recruiting

• Conditions: Chronic Liver Disease

• Registration Number: NCT05204251
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2022-04-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mental component of quality of Life of the	45 minutes	Assessment of the mental component of quality of life by a generic questionnaire (SF-36),

Trial Locations

Locations (1)

Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France; 🇫🇷 Strasbourg, France