Impact of lifestyle changes on liver health after TIPS procedure
Expanding the Therapeutic Landscape of Post-TIPS Hepatic Encephalopathy
NA · Hospital Clinic of Barcelona · NCT05346029
This study is testing whether making lifestyle changes can help improve liver health and reduce the risk of confusion in patients who have had a TIPS procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona (other) |
| Locations | 3 sites (Barcelona, Catalunya and 2 other locations) |
| Trial ID | NCT05346029 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of a 12-week lifestyle intervention aimed at reducing sarcopenia in patients who have undergone a transjugular intrahepatic portosystemic shunt (TIPS) procedure. It is a multicenter, open-label, randomized trial involving cirrhotic patients from three hospitals in Spain. Participants will be randomly assigned to either an intervention group, receiving lifestyle modifications, or an observational group, and will be monitored for the development of hepatic encephalopathy (HE) over six months. The study aims to identify risk factors and therapeutic interventions that could mitigate the incidence of post-TIPS HE.
Who should consider this trial
Good fit: Ideal candidates for this study are cirrhotic patients scheduled for elective TIPS placement.
Not a fit: Patients with contraindications for TIPS placement or physical therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of hepatic encephalopathy in patients undergoing TIPS, improving their overall health outcomes.
How similar studies have performed: While there have been studies addressing sarcopenia and hepatic encephalopathy, this specific approach combining lifestyle intervention post-TIPS is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All cirrhotic patients submitted for elective TIPS Exclusion Criteria: * Contraindication for TIPS placement, contraindication for physical therapy
Where this trial is running
Barcelona, Catalunya and 2 other locations
- Hospital Clínic de Barcelona — Barcelona, Catalunya, Spain (RECRUITING)
- Hospital Universitario Gregorio Marañón — Madrid, Spain (RECRUITING)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Anna Baiges, MD, PHD — Hospital Clinic of Barcelona
- Study coordinator: Anna Baiges, MD, PhD
- Email: abaigesa@clinic.cat
- Phone: 93 227 54 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis, Liver, Hepatic Encephalopathy, Sarcopenia, Transjugular intrahepatic portosystemic shunt, sarcopenia, microbioma, physical therapy, nutrition