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

NCT05204251 | Unknown

• 1 other identifier: 8338
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Liver Disease

Keywords

Chronic liver disease; TIPS; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Questionnaire BEHAVIORAL

Quality of Life assessed with the SF-36 questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Advanced Chronic Liver Disease who underwent a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement at the University Hospital of Strasbourg

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France

Strasbourg, 6720, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: April 11, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

FR (1)