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

NCT07163689 | Recruiting

• 1 other identifier: PI2025_843_0102
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• overall survival after TIPS placement

  at 3 months

• overall survival after TIPS placement

  at 6 months

• overall survival after TIPS placement

  at 1 year

• overall survival after TIPS placement

  at 2 years

• overall survival after TIPS placement

  at 3 years

• overall survival after TIPS placement

  at 4 years

• overall survival after TIPS placement

  at 5 years

Secondary Outcomes (28)

• free portal hypertension hemorrhage recurrence survival

  at 3 months

• free portal hypertension hemorrhage recurrence survival

  at 6 months

• free portal hypertension hemorrhage recurrence survival

  at 1 year

• free portal hypertension hemorrhage recurrence survival

  at 2 years

• free portal hypertension hemorrhage recurrence survival

  at 3 years

Study Arms (2)

group TIPS-PSVD

experimental group

TIPS-cirrhose

historical control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be retrospective and observational, collecting data provided in 24 tertiary french University Hospital (CHU). All patients with PSVD with a PH and treated by TIPS will be included (group TIPS\_PSDV) and compared with an historical group of patients with Cirrhosis with a TIPS (group TIPS-cirrhose).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal; Idiopathic Noncirrhotic Portal Hypertension; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eric NGUYEN-KHAC, Pr

CONTACT

33+3 22 08 88 51; nguyen-khac.eric@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 9, 2025
• Study Start: May 16, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)