TIPS for Complicated Portal Hypertension Related to Porto... | NCT07163689 | Trialant
NCT07163689
Sponsor
Centre Hospitalier Universitaire, Amiens
Status
Recruiting
Last Update Posted
Nov 19, 2025Actual
Enrollment
360Estimated
Phase
Not provided
Conditions
TIPS
Portal Hypertension
Porto-Sinusoidal Vascular Disease
Refractory Ascite
Esophageal Varices
Gastrointestinal Hemorrhage
Interventions
Not provided
Countries
France
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT07163689
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PI2025_843_0102
Secondary IDs
Not provided
Brief Title
TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
Official Title
TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
Acronym
TIPS-PSVD
Organization
Centre Hospitalier Universitaire, AmiensOTHER
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 16, 2025Actual
Primary Completion Date
Dec 2025Estimated
Completion Date
Dec 2025Estimated
First Submitted Date
Sep 2, 2025
First Submission Date that Met QC Criteria
Sep 2, 2025
First Posted Date
Sep 9, 2025Actual
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 18, 2025
Last Update Posted Date
Nov 19, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Centre Hospitalier Universitaire, AmiensOTHER
Collaborators
Name
Class
Groupe Hospitalier Pitie-Salpetriere
OTHER
Rennes University Hospital
OTHER
AP-HP - HU BEAUJON
UNKNOWN
University Hospital, Toulouse
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
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).