TIPSTIPS-PSVDNCT07163689
TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
An observational study of TIPS and Portal Hypertension, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TIPS, Portal Hypertension, Porto-Sinusoidal Vascular Disease
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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).
Who may be able to join
- 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)
Show all 10Show fewer
- Confirmed cirrhosis with :
- TIPS for digestive hemorrhage on portal hypertension
- TIPS for refractory ascite
- TIPS for portal vein thrombosis
Who cannot join
- no PSVD confirmed diagnosis
- Budd Chiari syndrome
- Rendu Osler disease; Heart failure
- Fontan; Sarcoïdosis
- Schistosomiase
- Congenitale liver fibrosis
Show all 9Show fewer
- Abernathy syndrome
- Tumor infiltration by lymphoma
- Bone graft
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Eric NGUYEN KHAC, PhD, +33322668883, nguyen-khac.eric@chu-amiens.fr
Marika Rudler, MD
About this study
Official title: 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
- Conditions
- TIPS, Portal Hypertension, Porto-Sinusoidal Vascular Disease, Refractory Ascite, Esophageal Varices, Gastrointestinal Hemorrhage
- Keywords
- TIPS, Portal hypertension, Porto-Sinusoidal Vascular disease, refractory ascite, esophageal varices, gastrointestinal hemorrhage
- Medical subject headings
- Hypertension, Portal, Idiopathic Noncirrhotic Portal Hypertension, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group TIPS-PSVD | experimental group | |
| TIPS-cirrhose | historical control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival after TIPS placement
Measured: at 3 months
overall survival after TIPS placement
Measured: at 6 months
overall survival after TIPS placement
Measured: at 1 year
overall survival after TIPS placement
Measured: at 2 years
overall survival after TIPS placement
Measured: at 3 years
overall survival after TIPS placement
Measured: at 4 years
overall survival after TIPS placement
Measured: at 5 years
Secondary outcomes (28)
free portal hypertension hemorrhage recurrence survival
Measured: at 3 months
free portal hypertension hemorrhage recurrence survival
Measured: at 6 months
free portal hypertension hemorrhage recurrence survival
Measured: at 1 year
free portal hypertension hemorrhage recurrence survival
Measured: at 2 years
free portal hypertension hemorrhage recurrence survival
Measured: at 3 years
free portal hypertension hemorrhage recurrence survival
Measured: at 4 years
free portal hypertension hemorrhage recurrence survival
Measured: at 5 years
free ascite recurrence survival
Measured: at 3 months
free ascite recurrence survival
Measured: at 6 months
free ascite recurrence survival
Measured: at 1 year
free ascite recurrence survival
Measured: at 2 years
free ascite recurrence survival
Measured: at 3 years
free ascite recurrence survival
Measured: at 4 years
free ascite recurrence survival
Measured: at 5 years
free TIPS dysfunction survival
Measured: at 3 months
free TIPS dysfunction survival
Measured: at 6 months
free TIPS dysfunction survival
Measured: at 1 year
free TIPS dysfunction survival
Measured: at 2 years
free TIPS dysfunction survival
Measured: at 3 years
free TIPS dysfunction survival
Measured: at 4 years
free TIPS dysfunction survival
Measured: at 5 years
complication of TIPS placement at D0
Measured: at 3 months
complication of TIPS placement at D0
Measured: at 6 months
complication of TIPS placement at D0
Measured: at 1 year
complication of TIPS placement at D0
Measured: at 2 years
complication of TIPS placement at D0
Measured: at 3 years
complication of TIPS placement at D0
Measured: at 4 years
complication of TIPS placement at D0
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start16 May 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TIPSStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Rennes University Hospital, AP-HP - HU BEAUJON, University Hospital, Toulouse, CHRU TOURS, Centre Hospitalier Universitaire de Besancon, Hospices Civils de Lyon, France, APHP - HOPITAL AVICENNE, University Hospital, Montpellier, Saint-Luc University Hospital, CHU Poitiers, Centre Hospitalier Universitaire de Nice, CH HENRI MONDOR, Saint Antoine University Hospital, University Hospital, Rouen, Hopital Paul Brousse, Nantes University Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Bordeaux, University Hospital, Brest, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163689
- Sponsor's protocol ID
- PI2025_843_0102
- Acronym
- TIPS-PSVD
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
- ClinicalTrials.gov ID
- NCT07163689
- Acronym / sponsor ID
- TIPS-PSVD / PI2025_843_0102
- Conditions
- TIPS, Portal Hypertension, Porto-Sinusoidal Vascular Disease, Refractory Ascite, Esophageal Varices, Gastrointestinal Hemorrhage
- Keywords
- TIPS, Portal hypertension, Porto-Sinusoidal Vascular disease, refractory ascite, esophageal varices, gastrointestinal hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Rennes University Hospital, AP-HP - HU BEAUJON, University Hospital, Toulouse, CHRU TOURS, Centre Hospitalier Universitaire de Besancon, Hospices Civils de Lyon, France, APHP - HOPITAL AVICENNE, University Hospital, Montpellier, Saint-Luc University Hospital, CHU Poitiers, Centre Hospitalier Universitaire de Nice, CH HENRI MONDOR, Saint Antoine University Hospital, University Hospital, Rouen, Hopital Paul Brousse, Nantes University Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Bordeaux, University Hospital, Brest, University Hospital, Clermont-Ferrand
- Study start
- 16 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group TIPS-PSVD | – | –experimental group |
| TIPS-cirrhose | – | –historical control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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).
Key inclusion criteria (10 listed)
- PSVD group :
- Patient with PSVD according VALDIG criteria
- TIPS for digestive hemorrhage on portal hypertension
- TIPS for refractory ascite
- TIPS for portal vein thrombosis
Key exclusion criteria (9 listed)
- no PSVD confirmed diagnosis
- Budd Chiari syndrome
- Rendu Osler disease; Heart failure
- Fontan; Sarcoïdosis
- Schistosomiase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival after TIPS placement
Time frame: at 3 months
overall survival after TIPS placement
Time frame: at 6 months
overall survival after TIPS placement
Time frame: at 1 year
overall survival after TIPS placement
Time frame: at 2 years
overall survival after TIPS placement
Time frame: at 3 years
overall survival after TIPS placement
Time frame: at 4 years
overall survival after TIPS placement
Time frame: at 5 years
28 secondary outcomes
free portal hypertension hemorrhage recurrence survival
Time frame: at 3 months
free portal hypertension hemorrhage recurrence survival
Time frame: at 6 months
free portal hypertension hemorrhage recurrence survival
Time frame: at 1 year
free portal hypertension hemorrhage recurrence survival
Time frame: at 2 years
free portal hypertension hemorrhage recurrence survival
Time frame: at 3 years
free portal hypertension hemorrhage recurrence survival
Time frame: at 4 years
free portal hypertension hemorrhage recurrence survival
Time frame: at 5 years
free ascite recurrence survival
Time frame: at 3 months
free ascite recurrence survival
Time frame: at 6 months
free ascite recurrence survival
Time frame: at 1 year
free ascite recurrence survival
Time frame: at 2 years
free ascite recurrence survival
Time frame: at 3 years
free ascite recurrence survival
Time frame: at 4 years
free ascite recurrence survival
Time frame: at 5 years
free TIPS dysfunction survival
Time frame: at 3 months
free TIPS dysfunction survival
Time frame: at 6 months
free TIPS dysfunction survival
Time frame: at 1 year
free TIPS dysfunction survival
Time frame: at 2 years
free TIPS dysfunction survival
Time frame: at 3 years
free TIPS dysfunction survival
Time frame: at 4 years
free TIPS dysfunction survival
Time frame: at 5 years
complication of TIPS placement at D0
Time frame: at 3 months
complication of TIPS placement at D0
Time frame: at 6 months
complication of TIPS placement at D0
Time frame: at 1 year
complication of TIPS placement at D0
Time frame: at 2 years
complication of TIPS placement at D0
Time frame: at 3 years
complication of TIPS placement at D0
Time frame: at 4 years
complication of TIPS placement at D0
Time frame: at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Development and Validation of a TIPS Prognostic Model
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Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
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Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TIPS and Portal Hypertension, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric NGUYEN-KHAC, Pr (33+3 22 08 88 51, nguyen-khac.eric@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival after TIPS placement (time frame: at 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.