NCT07163689 TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
| NCT ID | NCT07163689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | TIPS |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2025-05-16 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Porto-sinusoidal Vascular Disease (PSVD) is characterized by a portal hypertension (PH) without cirrhosis. This can induce PH complications, like digestive hemorrhage from esophageal or gastric varices, ascites, or even portal thrombosis. Due to the rarity of MVPS, the treatment of complications of portal hypertension is modeled on the methods used in cirrhotic portal hypertension with non-cardio-selective beta blockers, endoscopic ligations or diuretics in first line therapy, as proposed by the Baveno VII recommendations. In complicated or refractory forms of PH in PSVD, the place of TIPS is also discussed, as in the field of cirrhosis. However, the experience of TIPS in PSVD is limited, reported in case reports and small specifically dedicated series. No predictive factors for survival or recurrence and tolerance were well known. A larger study with control group is needed in order to better know the right time and the right indication for the use of TIPS in complicated PH PSVD-related. The study will be retrospective, multicentric involving tertiary university French centers, expert in the management of TIPS. Patients white TIPS-PSVD will be compared with historical patients with TIPS-cirrhose, matched on age, sexe, indication of TIPS. The study will not comprise new intervention, only observational in a real life condition
Eligibility Criteria
Inclusion Criteria: * PSVD group : * Patient with PSVD according VALDIG criteria * TIPS for digestive hemorrhage on portal hypertension * TIPS for refractory ascite * TIPS for portal vein thrombosis * Cirrhosis group with PH : (appaired by age, sexe, type of PH complications) * Confirmed cirrhosis with : * TIPS for digestive hemorrhage on portal hypertension * TIPS for refractory ascite * TIPS for portal vein thrombosis Exclusion Criteria: * no PSVD confirmed diagnosis * Budd Chiari syndrome * Rendu Osler disease; Heart failure * Fontan; Sarcoïdosis * Schistosomiase * Congenitale liver fibrosis * Abernathy syndrome * Tumor infiltration by lymphoma * Bone graft
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07163689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying TIPS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07163689 currently recruiting?
Yes, NCT07163689 is actively recruiting participants. Contact the research team at nguyen-khac.eric@chu-amiens.fr for enrollment information.
Where is the NCT07163689 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT07163689 clinical trial?
NCT07163689 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 360 participants.