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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with PSVD according VALDIG criteria

TIPS for digestive hemorrhage on portal hypertension

TIPS for refractory ascite

TIPS for portal vein thrombosis

Disqualifiers

no PSVD confirmed diagnosis

Budd Chiari syndrome

Rendu Osler disease; Heart failure

Fontan; Sarcoïdosis

Trial 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).

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

360 Participants
are grouped into 2 trial groups
Group A: group TIPS-PSVD
Group B: TIPS-cirrhose

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborator

Rennes University Hospital

Collaborator

AP-HP - HU BEAUJON

Collaborator

University Hospital, Toulouse

Collaborator

CHRU TOURS

Collaborator

Centre Hospitalier Universitaire de Besancon

Collaborator

Hospices Civils de Lyon, France

Collaborator

APHP - HOPITAL AVICENNE

Collaborator

University Hospital, Montpellier

Collaborator

Saint-Luc University Hospital

Collaborator

CHU Poitiers

Collaborator

Centre Hospitalier Universitaire de Nice

Collaborator

CH HENRI MONDOR

Collaborator

Saint Antoine University Hospital

Collaborator

University Hospital, Rouen

Collaborator

Hopital Paul Brousse

Collaborator

Nantes University Hospital

Collaborator

Centre Hospitalier Universitaire Dijon

Collaborator

University Hospital, Bordeaux

Collaborator

University Hospital, Brest

Collaborator

University Hospital, Clermont-Ferrand

Collaborator