TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease

Recruiting

• Conditions: TIPS; Portal Hypertension; Porto-Sinusoidal Vascular Disease; Refractory Ascite; Esophageal Varices; Gastrointestinal Hemorrhage

• Registration Number: NCT07163689
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-16
• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Primary Completion: 2025-10
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival after TIPS placement	at 5 years

Secondary Outcome Measures

Name	Time	Method
free TIPS dysfunction survival	at 5 years
free portal hypertension hemorrhage recurrence survival	at 5 years
free ascite recurrence survival	at 5 years
complication of TIPS placement at D0	at 5 years

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France