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NCT Number: NCT07163689

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Armando ABERGEL, MD

PRINCIPAL_INVESTIGATOR

Audrey COILLY, MD

PRINCIPAL_INVESTIGATOR

Christine SILVAIN, MD

PRINCIPAL_INVESTIGATOR

Christophe Bureau, MD

PRINCIPAL_INVESTIGATOR

Dominique CAZALS-HATEM, MD

PRINCIPAL_INVESTIGATOR

Eric NGUYEN KHAC, PhD

CONTACT

[email protected]

+33322668883

Florent Artru, MD

PRINCIPAL_INVESTIGATOR

Giuliana AMADDEO, MD

PRINCIPAL_INVESTIGATOR

Géraldine DAHLQVIST, MD

PRINCIPAL_INVESTIGATOR

Jean Charles Nault, MD

PRINCIPAL_INVESTIGATOR

Jean Paul CERVONI, MD

PRINCIPAL_INVESTIGATOR

Jerome GOURNAY, MD

PRINCIPAL_INVESTIGATOR

Jérome Dumortier, MD

PRINCIPAL_INVESTIGATOR

Laure Elkrief, MD

PRINCIPAL_INVESTIGATOR

Magdalena MESZAROS, MD

PRINCIPAL_INVESTIGATOR

Marika Rudler, MD

PRINCIPAL_INVESTIGATOR

Nicolas CARBONELL, MD

PRINCIPAL_INVESTIGATOR

Noémie REBOUX, MD

PRINCIPAL_INVESTIGATOR

Odile GORIA, MD

PRINCIPAL_INVESTIGATOR

Paul HERBAMESSIERE, MD

PRINCIPAL_INVESTIGATOR

Pierre Emmanuel Rautou, MD

PRINCIPAL_INVESTIGATOR

Rodolphe ANTY, MD

PRINCIPAL_INVESTIGATOR

Théophile GERSTER, MD

PRINCIPAL_INVESTIGATOR

Térésa ANTONINI, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. overall survival after TIPS placement

    Time frame: at 3 months

  2. overall survival after TIPS placement

    Time frame: at 6 months

  3. overall survival after TIPS placement

    Time frame: at 1 year

  4. overall survival after TIPS placement

    Time frame: at 2 years

  5. overall survival after TIPS placement

    Time frame: at 3 years

  6. overall survival after TIPS placement

    Time frame: at 4 years

  7. overall survival after TIPS placement

    Time frame: at 5 years

Secondary outcomes

  1. free portal hypertension hemorrhage recurrence survival

    Time frame: at 3 months

  2. free portal hypertension hemorrhage recurrence survival

    Time frame: at 6 months

  3. free portal hypertension hemorrhage recurrence survival

    Time frame: at 1 year

  4. free portal hypertension hemorrhage recurrence survival

    Time frame: at 2 years

  5. free portal hypertension hemorrhage recurrence survival

    Time frame: at 3 years

  6. free portal hypertension hemorrhage recurrence survival

    Time frame: at 4 years

  7. free portal hypertension hemorrhage recurrence survival

    Time frame: at 5 years

  8. free ascite recurrence survival

    Time frame: at 3 months

  9. free ascite recurrence survival

    Time frame: at 6 months

  10. free ascite recurrence survival

    Time frame: at 1 year

  11. free ascite recurrence survival

    Time frame: at 2 years

  12. free ascite recurrence survival

    Time frame: at 3 years

  13. free ascite recurrence survival

    Time frame: at 4 years

  14. free ascite recurrence survival

    Time frame: at 5 years

  15. free TIPS dysfunction survival

    Time frame: at 3 months

  16. free TIPS dysfunction survival

    Time frame: at 6 months

  17. free TIPS dysfunction survival

    Time frame: at 1 year

  18. free TIPS dysfunction survival

    Time frame: at 2 years

  19. free TIPS dysfunction survival

    Time frame: at 3 years

  20. free TIPS dysfunction survival

    Time frame: at 4 years

  21. free TIPS dysfunction survival

    Time frame: at 5 years

  22. complication of TIPS placement at D0

    Time frame: at 3 months

  23. complication of TIPS placement at D0

    Time frame: at 6 months

  24. complication of TIPS placement at D0

    Time frame: at 1 year

  25. complication of TIPS placement at D0

    Time frame: at 2 years

  26. complication of TIPS placement at D0

    Time frame: at 3 years

  27. complication of TIPS placement at D0

    Time frame: at 4 years

  28. complication of TIPS placement at D0

    Time frame: at 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Eric NGUYEN-KHAC, Pr

CONTACT

[email protected]

33+3 22 08 88 51

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TIPS-PSVD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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