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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-16

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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TIPS Portal Hypertension Porto-Sinusoidal Vascular Disease Refractory Ascite Esophageal Varices Gastrointestinal Hemorrhage

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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group TIPS-PSVD

experimental group

No interventions assigned to this group

TIPS-cirrhose

historical control group

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No