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

October 6, 2023 updated by: University Hospital, Strasbourg, France

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 6720
        • Recruiting
        • Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Pierre DE MARINI
        • Sub-Investigator:
          • Michel GREGET
        • Sub-Investigator:
          • François FAITOT
        • Sub-Investigator:
          • Afshin GANGI
        • Sub-Investigator:
          • Emanuele BOATTA
        • Sub-Investigator:
          • Roberto Luigi CAZZATO
        • Sub-Investigator:
          • Iulian ENESCU
        • Sub-Investigator:
          • Camille BESCH
        • Sub-Investigator:
          • Baptiste MICHARD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental component of quality of Life of the
Time Frame: 45 minutes
Assessment of the mental component of quality of life by a generic questionnaire (SF-36),
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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