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NCT07163689Recruiting

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

Source: ClinicalTrials.gov · Last updated 19 Nov 2025

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
360 (estimated)
First submitted
2 Sept 2025
Start date
16 May 2025
Primary completion date
Dec 2025
Lead sponsor
Centre Hospitalier Universitaire, Amiens
NCT number
NCT07163689

What you commit to

  • Study type: Observational
  • Planned participants: 360
  • From 16 May 2025 to the primary completion date, Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Budd Chiari syndrome
  • Rendu Osler disease; Heart failure
  • Abernathy syndrome

Other

  • no PSVD confirmed diagnosis
  • Fontan; Sarcoïdosis
  • Schistosomiase
  • Congenitale liver fibrosis
  • Tumor infiltration by lymphoma
  • Bone graft

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Amiens Picardie
Coordinator of this site? Confirm its status
AmiensFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.