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

November 18, 2025 updated by: Centre Hospitalier Universitaire, Amiens

TIPS for the Management of 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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • Recruiting
        • CHU Amiens Picardie
        • Principal Investigator:
          • Rodolphe ANTY, MD
        • Principal Investigator:
          • Giuliana AMADDEO, MD
        • Principal Investigator:
          • Jérome Dumortier, MD
        • Principal Investigator:
          • Marika Rudler, MD
        • Principal Investigator:
          • Christine SILVAIN, MD
        • Principal Investigator:
          • Odile GORIA, MD
        • Principal Investigator:
          • Audrey COILLY, MD
        • Principal Investigator:
          • Teresa ANTONINI, MD
        • Principal Investigator:
          • Christophe Bureau, MD
        • Contact:
        • Principal Investigator:
          • Florent Artru, MD
        • Principal Investigator:
          • Laure Elkrief, MD
        • Principal Investigator:
          • Géraldine DAHLQVIST, MD
        • Principal Investigator:
          • Pierre Emmanuel Rautou, MD
        • Principal Investigator:
          • Jean Paul CERVONI, MD
        • Principal Investigator:
          • Jean Charles Nault, MD
        • Principal Investigator:
          • Magdalena MESZAROS, MD
        • Principal Investigator:
          • Nicolas CARBONELL, MD
        • Principal Investigator:
          • Jerome GOURNAY, MD
        • Principal Investigator:
          • Théophile GERSTER, MD
        • Principal Investigator:
          • Paul HERBAMESSIERE, MD
        • Principal Investigator:
          • Noémie REBOUX, MD
        • Principal Investigator:
          • Armando ABERGEL, MD
        • Principal Investigator:
          • Dominique CAZALS-HATEM, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
group TIPS-PSVD
experimental group
TIPS-cirrhose
historical control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival after TIPS placement
Time Frame: at 3 months
at 3 months
overall survival after TIPS placement
Time Frame: at 6 months
at 6 months
overall survival after TIPS placement
Time Frame: at 1 year
at 1 year
overall survival after TIPS placement
Time Frame: at 2 years
at 2 years
overall survival after TIPS placement
Time Frame: at 3 years
at 3 years
overall survival after TIPS placement
Time Frame: at 4 years
at 4 years
overall survival after TIPS placement
Time Frame: at 5 years
at 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
free portal hypertension hemorrhage recurrence survival
Time Frame: at 3 months
at 3 months
free portal hypertension hemorrhage recurrence survival
Time Frame: at 6 months
at 6 months
free portal hypertension hemorrhage recurrence survival
Time Frame: at 1 year
at 1 year
free portal hypertension hemorrhage recurrence survival
Time Frame: at 2 years
at 2 years
free portal hypertension hemorrhage recurrence survival
Time Frame: at 3 years
at 3 years
free portal hypertension hemorrhage recurrence survival
Time Frame: at 4 years
at 4 years
free portal hypertension hemorrhage recurrence survival
Time Frame: at 5 years
at 5 years
free ascite recurrence survival
Time Frame: at 3 months
at 3 months
free ascite recurrence survival
Time Frame: at 6 months
at 6 months
free ascite recurrence survival
Time Frame: at 1 year
at 1 year
free ascite recurrence survival
Time Frame: at 2 years
at 2 years
free ascite recurrence survival
Time Frame: at 3 years
at 3 years
free ascite recurrence survival
Time Frame: at 4 years
at 4 years
free ascite recurrence survival
Time Frame: at 5 years
at 5 years
free TIPS dysfunction survival
Time Frame: at 3 months
at 3 months
free TIPS dysfunction survival
Time Frame: at 6 months
at 6 months
free TIPS dysfunction survival
Time Frame: at 1 year
at 1 year
free TIPS dysfunction survival
Time Frame: at 2 years
at 2 years
free TIPS dysfunction survival
Time Frame: at 3 years
at 3 years
free TIPS dysfunction survival
Time Frame: at 4 years
at 4 years
free TIPS dysfunction survival
Time Frame: at 5 years
at 5 years
complication of TIPS placement at D0
Time Frame: at 3 months
at 3 months
complication of TIPS placement at D0
Time Frame: at 6 months
at 6 months
complication of TIPS placement at D0
Time Frame: at 1 year
at 1 year
complication of TIPS placement at D0
Time Frame: at 2 years
at 2 years
complication of TIPS placement at D0
Time Frame: at 3 years
at 3 years
complication of TIPS placement at D0
Time Frame: at 4 years
at 4 years
complication of TIPS placement at D0
Time Frame: at 5 years
at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 2, 2025

First Submitted That Met QC Criteria

September 2, 2025

First Posted (Estimated)

September 9, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2025_843_0102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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