Actively Recruiting

Age: 18Years +
All Genders
NCT07163689

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-19

360

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

G

Groupe Hospitalier Pitie-Salpetriere

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with PSVD according to VALDIG criteria
  • TIPS performed for digestive hemorrhage due to portal hypertension
  • TIPS performed for refractory ascites
  • TIPS performed for portal vein thrombosis
  • Confirmed cirrhosis with portal hypertension
  • TIPS performed for digestive hemorrhage due to portal hypertension in cirrhosis patients
  • TIPS performed for refractory ascites in cirrhosis patients
  • TIPS performed for portal vein thrombosis in cirrhosis patients
Not Eligible

You will not qualify if you...

  • No confirmed diagnosis of PSVD
  • Budd Chiari syndrome
  • Rendu Osler disease
  • Heart failure
  • Fontan procedure
  • Sarcoidosis
  • Schistosomiasis
  • Congenital liver fibrosis
  • Abernathy syndrome
  • Tumor infiltration by lymphoma
  • Bone graft

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Amiens Picardie

Amiens, Picardie, France, 80054

Actively Recruiting

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Research Team

E

Eric NGUYEN-KHAC, Pr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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