Status:
RECRUITING
Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study (POEME)
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Société nationale française de gastro-entérologie
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
TIPS is a standard for the treatment of portal hypertension related complications. However, it remains at risk of HE after TIPS (around 40% the first year). Dysbiosis plays a key role in pathophysiolo...
Detailed Description
TIPS is a standard for the treatment of portal hypertension related complications. However, it remains at risk of HE after TIPS (around 40% the first year). Dysbiosis plays a key role in pathophysiolo...
Eligibility Criteria
Inclusion
- Male or female at least 18 years of age
- Affected (c) cirrhosis in which the establishment of a TIPS is scheduled within the month for: the treatment of ascites or a refractory hydrothorax or the prevention of the recurrence of a related digestive hemorrhage portal hypertension
- Having signed the consent to participate in the study
- Women of childbearing age on effective contraception
- Affiliated to a social security scheme
Exclusion
- Contraindication for TIPS
- Digestive short circuit, chronic inflammatory bowel diseases
- Indications of TIPS in emergency or as part of the preparation for a surgical procedure,
- Liver transplant,
- Patient for whom the follow-up is considered impossible due to non-compliance with care or because the vital prognosis is estimated less than 6 months because of an incurable chronic pathology,
- Pregnant or lactating women,
- Those unable to receive enlightened information,
- Those participating in another interventional research including an exclusion period
- Persons placed under safeguard of justice, tutelage or curators.
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05206487
Start Date
May 9 2022
End Date
June 30 2025
Last Update
April 30 2024
Active Locations (1)
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1
Toulouse University Hospital
Toulouse, France, 31059