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

NCT07163689 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2025-11-19

No results posted yet for this study

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

Sponsors & Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

    collaborator OTHER
  • CHU Rennes

    collaborator UNKNOWN
  • AP-HP - HU BEAUJON

    collaborator UNKNOWN
  • University Hospital, Toulouse

    collaborator OTHER
  • CHRU TOURS

    collaborator UNKNOWN
  • Centre Hospitalier Universitaire de Besancon

    collaborator OTHER
  • Hospices Civils de Lyon, France

    collaborator UNKNOWN
  • APHP - HOPITAL AVICENNE

    collaborator UNKNOWN
  • University Hospital, Montpellier

    collaborator OTHER
  • Saint-Luc University Hospital

    collaborator UNKNOWN
  • CHU Poitiers

    collaborator UNKNOWN
  • CHU NICE

    collaborator UNKNOWN
  • CH HENRI MONDOR

    collaborator UNKNOWN
  • Saint Antoine University Hospital

    collaborator OTHER
  • University Hospital, Rouen

    collaborator OTHER
  • AP-HP Paul Brousse University Hospital

    collaborator UNKNOWN
  • Nantes University Hospital

    collaborator OTHER
  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER
  • University Hospital, Bordeaux

    collaborator OTHER
  • University Hospital, Brest

    collaborator OTHER
  • University Hospital, Clermont-Ferrand

    collaborator OTHER
  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-16
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07163689 on ClinicalTrials.gov