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

Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt (TIPS) - Pilot Observational Cross-sectional Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05204251
Acronym
TIPS
Enrollment
45
Registered
2022-01-24
Start date
2022-04-11
Completion date
2024-04-30
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease

Keywords

Chronic liver disease, TIPS, Quality of life

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).

Interventions

BEHAVIORALQuestionnaire

Quality of Life assessed with the SF-36 questionnaire

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mental component of quality of Life of the45 minutesAssessment of the mental component of quality of life by a generic questionnaire (SF-36),

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026