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RecruitingNCT05204251TIPSUpdated Oct 10, 2023

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

An observational study in Chronic Liver Disease, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
45
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Chronic Liver Disease

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Keywords

  • Chronic liver disease
  • TIPS
  • Quality of life
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 45 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
45 participants (estimated)
Patient registry
No

Interventions

  • BehavioralQuestionnaire

    Quality of Life assessed with the SF-36 questionnaire

06

What researchers measure

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),

    Time frame: 45 minutes

07

Study locations

1 of 1 sites recruiting
  • Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France
    Strasbourg, 6720, France
    • Pierre DE MARINI · Contact · pierre.demarini@chru-strasbourg.fr · +33 3.88.12.71.43
    • Pierre DE MARINI · Principal 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 · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05204251
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jan 24, 2022
Start date
Apr 11, 2022
Primary completion
Apr 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Oct 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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