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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07163689
Acronym
TIPS-PSVD
Enrollment
360
Registered
2025-09-09
Start date
2025-05-16
Completion date
2025-12-31
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

TIPS, Portal hypertension, Porto-Sinusoidal Vascular disease, refractory ascite, esophageal varices, gastrointestinal hemorrhage

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

Interventions

None listed

Sponsors

Groupe Hospitalier Pitie-Salpetriere
CollaboratorOTHER
CHU Rennes
CollaboratorUNKNOWN
AP-HP - HU BEAUJON
CollaboratorUNKNOWN
University Hospital, Toulouse
CollaboratorOTHER
CHRU TOURS
CollaboratorUNKNOWN
Centre Hospitalier Universitaire de Besancon
CollaboratorOTHER
Hospices Civils de Lyon, France
CollaboratorUNKNOWN
APHP - HOPITAL AVICENNE
CollaboratorUNKNOWN
University Hospital, Montpellier
CollaboratorOTHER
Saint-Luc University Hospital
CollaboratorUNKNOWN
CHU Poitiers
CollaboratorUNKNOWN
CHU NICE
CollaboratorUNKNOWN
CH HENRI MONDOR
CollaboratorUNKNOWN
Saint Antoine University Hospital
CollaboratorOTHER
University Hospital, Rouen
CollaboratorOTHER
AP-HP Paul Brousse University Hospital
CollaboratorUNKNOWN
Nantes University Hospital
CollaboratorOTHER
Centre Hospitalier Universitaire Dijon
CollaboratorOTHER
University Hospital, Bordeaux
CollaboratorOTHER
University Hospital, Brest
CollaboratorOTHER
University Hospital, Clermont-Ferrand
CollaboratorOTHER
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
overall survival after TIPS placementat 3 months

Secondary

MeasureTime frame
free portal hypertension hemorrhage recurrence survivalat 3 months
free ascite recurrence survivalat 3 months
free TIPS dysfunction survivalat 3 months
complication of TIPS placement at D0at 3 months

Countries

France

Contacts

Primary ContactEric NGUYEN-KHAC, Pr
nguyen-khac.eric@chu-amiens.fr33+3 22 08 88 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026