Expanding the Therapeutic Landscape of Post-TIPS Hepatic Encephalopathy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The placement of TIPS (transjugular intrahepatic portosystemic shunt) is the most effective strategy to treat complications of portal hypertension. However, the threat of developing post-TIPS complications diminishes its use and applicability. Hepatic encephalopathy (HE) is the most feared and frequent post-TIPS complication, affecting between 25-54% of patients. Available treatments against HE are only partially effective. Therefore, the best existing strategy is to accurately select patients for TIPS excluding those presenting known high risk factors associated to post-TIPS HE. Despite applying this approach, the incidence of post-TIPS HE still remains very high. The investigators hypothesize that a better identification of risk factors for post-TIPS HE, together with the introduction of therapeutic interventions modulating pathophysiological mechanisms involved in post-TIPS HE development - among which sarcopenia stands out- would lead to a reduction in the incidence of HE and, eventually, to an increase in the number of patients benefiting from TIPS. Thus, our project is aimed at 1. Demonstrate that a 12 weeks lifestyle intervention based on resistance training and nutritional counseling can reduce sarcopenia and, ultimately, post-TIPS HE. 2. To study predictive factors of post-TIPS HE, focusing on the role of factors that have never been evaluated in the setting of TIPS: gut microbiome and cognitive function

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All cirrhotic patients submitted for elective TIPS

Locations
Other Locations
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Contact Information
Primary
Anna Baiges, MD, PhD
abaigesa@clinic.cat
93 227 54 00
Backup
Joan Carles García Pagan, MD, PhD
jcgarcia@clinic.cat
93 227 54 00
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 140
Treatments
No_intervention: Standard of care
Patients will be followed-up according to standard clinical practices
Experimental: Lifestyle intervention
Patients will undergo a 12 week lifestyle intervention (physical therapy and nutritional assessment)
Sponsors
Leads: Anna Baiges
Collaborators: Hospital Universitario Ramon y Cajal, Instituto de Salud Carlos III, Gregorio Marañón Hospital

This content was sourced from clinicaltrials.gov