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

NCT ID: NCT05204251

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-11

Study Completion Date

2024-04-30

Brief Summary

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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

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Conditions

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Chronic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Questionnaire

Quality of Life assessed with the SF-36 questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Pierre DE MARINI

Role: primary

+33 3.88.12.71.43

Other Identifiers

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8338

Identifier Type: -

Identifier Source: org_study_id

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