Hypertension, PortalPRIMO-01NCT07873021
Percutaneous Portal Vein Recanalization for Refractory Portal Hypertension in Children With Non-Cirrhotic Extrahepatic Portal Vein Obstruction
An observational study of Hypertension, Portal and Interventional Radiology, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
This monocentric, prospective, observational study aims to evaluate the clinical efficacy, safety, and technical success of percutaneous portal vein recanalization (PVR) performed via interventional radiology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Portal, Interventional Radiology, Percutaneous Portal Vein Recanalization (PVR)
- What is being tested?
- Percutaneous Portal Vein Recanalization (PVR)
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 31 May 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric patients treated at the ASST Papa Giovanni XXIII hospital in Bergamo, Italy (specifically identified through the Radiology 1, Pediatric Hematology, and Pediatric Surgery units). The study population comprises individuals who underwent percutaneous recanalization for non-cirrhotic extrahepatic portal vein obstruction between January 1, 2022, and November 30, 2026, and are currently undergoing routine clinical and radiological follow-up.
Who may be able to join
- < 18-year-old patients (with exception of patients > 17-year-old if they had a history of non-cirrhotic EHPVO since infancy)
- Portal hypertension resulting from non-cirrhotic EHPVO defined by the presence of at least one of the following: clinical hypersplenism; platelet count < 150,000 platelets per microliter; history of high risk or bleeding gastrointestinal varices
- Patients not eligible for, or not willing to undergo Meso-Rex bypass surgery
Who cannot join
- Primary hepatocellular disease (infectious or any other)
- Any technical contraindication to PVR
- Histology proven fibrosis/cirrhosis (clinically significant >=F2)
Trial locations and contacts
1 site in 1 country.
Italy1 site
ASST PAPA GIOVANNI XXIII - Piazza OMS-1, 24127 Bergamo
Bergamo, BG, 24127
About this study
Official title: Percutaneous Portal Vein Recanalization (PVR) by Interventional Radiology for the Management of Refractory Portal Hypertension in Children With Non-cirrhotic Extrahepatic Portal Vein Obstruction.
This monocentric, prospective, observational study aims to evaluate the clinical efficacy, safety, and technical success of percutaneous portal vein recanalization (PVR) performed via interventional radiology. The procedure targets pediatric patients suffering from refractory portal hypertension due to non-cirrhotic extrahepatic portal vein obstruction (EHPVO) who are either ineligible for, or unwilling to undergo, standard physiological surgical options such as the Meso-Rex bypass.
- Conditions
- Hypertension, Portal, Interventional Radiology, Percutaneous Portal Vein Recanalization (PVR), Extrahepatic Portal Vein Obstruction (EHPVO), Portal Vein Thrombosis, Cavernous Transformation of Portal Vein
- Being tested
- Percutaneous Portal Vein Recanalization (PVR)
- Keywords
- Portal Hypertension, Non-Cirrhotic Extrahepatic Portal Vein Obstruction (EHPVO), Portal Vein Thrombosis, Percutaneous Portal Vein Recanalization (PVR), Angioplasty, Stenting, Endovascular
- Medical subject headings
- Hypertension, Portal, Portal Vein, Cavernous Transformation Of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Portal Vein Recanalization (PVR)Procedure or surgery
Also called Portal Vein Recanalization
Intervention Description: Percutaneous portal vein recanalization (PVR) is a minimally invasive endovascular procedure performed via interventional radiology to restore portal blood flow in pediatric patients with non-cirrhotic extrahepatic portal vein obstruction (EHPVO).
The procedure utilizes catheter-based techniques, consisting of balloon angioplasty alone or combined with endovascular stent placement, tailored to individual anatomy. Unlike traditional surgical options (such as Meso-Rex bypass) or non-physiological shunts, PVR re-establishes portal perfusion directly into the native hepatic circulation via a percutaneous route for patients ineligible for or unwilling to undergo surgery. The intervention also includes post-procedural antithrombotic medical therapy. Patients who failed PVR are investigated for alternative treatment strategies including: trans jugular intrahepatic portosystemic shunt (TIPS), Meso-Rex bypass (MRB) and surgical shunts.
| Study group | Role | What they receive |
|---|---|---|
| Children with non-cirrhotic extrahepatic portal vein Obstruction | This cohort includes pediatric patients (< 18 years old) with non-cirrhotic extrahepatic portal vein obstruction (EHPVO) and refractory portal hypertension. Patients in this group present with at least one of the following: clinical hypersplenism, platelet count < 150,000/ml, or a history of high-risk/bleeding gastrointestinal varices. All included participants are individuals who were either not eligible for, or unwilling to undergo, standard surgical options (such as the Meso-Rex bypass) and have undergone percutaneous portal vein recanalization (PVR) as part of their routine clinical care. Receives: Procedure: Percutaneous Portal Vein Recanalization (PVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Hematologic Parameters
Evaluation of change from baseline in Red Blood Cell (RBC), White Blood Cell (WBC) and Platelet counts, evaluated at 6,12,24 and 36 month post PVR
Measured: up to 36 months
Status of Esophagogastric Varices
Assessment of changes in esophagogastric varices during follow-up upper gastrointestinal endoscopy.
Measured: up to 36 months
Change in Spleen Stiffness
Assessment of the change in spleen stiffness measured by shear wave elastography (SWE) compared to baseline values.
Measured: up to 36 months
Change in Spleen Diameter
Evaluation of changes in spleen longitudinal diameter relative to age-specific normal ranges and baseline measurements over time.
Measured: up to 36 months
Incidence of Gastrointestinal Bleeding Events
Assessment of the occurrence or recurrence of gastrointestinal bleeding episodes during the observation period.
Measured: up to 36 monts
Secondary outcomes (7)
Rate of Technical Success
Percentage of procedures achieving restoration of portal blood flow assessed by final procedural venography.
Measured: Up to 36 months post-procedure
Portal Vein Patency Rate
Percentage of patients with patent portal veins evaluated via color Doppler ultrasound and/or CT venography at 3, 6, 12, 24, and 36 months.
Measured: up to 36 months post-procedures
Incidence of Portal Vein Reocclusion
Frequency and patterns of portal vein reocclusion evaluated during follow-up.
Measured: up to 36 months post-procedures
Diagnostic Accuracy of Spleen SWE
Evaluation of the diagnostic accuracy of spleen shear wave elastography in predicting portal vein patency or occlusion.
Measured: up to 36 month post-procedures
Rate of Procedure-Related Complications
Incidence and severity of complications classified using CIRSE or Clavien-Dindo criteria.
Measured: up to 36 months post-procedures
Radiation and Contrast Exposure
Cumulative volume of contrast agent and ionizing radiation exposure during the procedure.
Measured: up to 36 months post-procedures
Comparative Outcomes by Technique
Comparison of outcomes between balloon angioplasty alone versus angioplasty with stent placement.
Measured: up to 36 months post-procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Jan 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PortalStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Marra, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873021
- Sponsor's protocol ID
- 0044092/25
- Acronym
- PRIMO-01
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martins de Mattos KD, Marra P, Carbone FS, Muglia R, Dulcetta L, Fagiuoli S, D'Antiga L, Sironi S. Non-anatomical revascularization of the portal vein in children with non-cirrhotic extrahepatic portal vein obstruction. Pediatr Radiol. 2025 May;55(6):1308-1312. doi: 10.1007/s00247-025-06218-1. Epub 2025 Mar 19.
PubMed 40105912Marra P, Franchi-Abella S, Hernandez JA, Ronot M, Muglia R, D'Antiga L, Sironi S. Percutaneous recanalization of non-cirrhotic extrahepatic portal vein obstruction in children: technical considerations in a preliminary cohort. Eur Radiol. 2025 Jun;35(6):3262-3269. doi: 10.1007/s00330-024-11040-8. Epub 2024 Sep 6.
PubMed 39242398Marra P, Franchi-Abella S, Sironi S. Portal Vein Recanalization in Children: Expanding Physiological Restoration Beyond the Meso-Rex Bypass. Cardiovasc Intervent Radiol. 2026 Mar 30. doi: 10.1007/s00270-026-04419-1. Online ahead of print. No abstract available.
PubMed 41910605
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Portal Vein Recanalization (PVR) by Interventional Radiology for the Management of Refractory Portal Hypertension in Children With Non-cirrhotic Extrahepatic Portal Vein Obstruction.
- ClinicalTrials.gov ID
- NCT07873021
- Acronym / sponsor ID
- PRIMO-01 / 0044092/25
- Conditions
- Hypertension, Portal, Interventional Radiology, Percutaneous Portal Vein Recanalization (PVR), Extrahepatic Portal Vein Obstruction (EHPVO), Portal Vein Thrombosis, Cavernous Transformation of Portal Vein
- Keywords
- Portal Hypertension, Non-Cirrhotic Extrahepatic Portal Vein Obstruction (EHPVO), Portal Vein Thrombosis, Percutaneous Portal Vein Recanalization (PVR), Angioplasty, Stenting, Endovascular
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 14 Oct 2026 (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.
This monocentric, prospective, observational study aims to evaluate the clinical efficacy, safety, and technical success of percutaneous portal vein recanalization (PVR) performed via interventional radiology. The procedure targets pediatric patients suffering from refractory portal hypertension due to non-cirrhotic extrahepatic portal vein obstruction (EHPVO) who are either ineligible for, or unwilling to undergo, standard physiological surgical options such as the Meso-Rex bypass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with non-cirrhotic extrahepatic portal vein Obstruction | – | Procedure: Percutaneous Portal Vein Recanalization (PVR)This cohort includes pediatric patients (< 18 years old) with non-cirrhotic extrahepatic portal vein obstruction (EHPVO) and refractory portal hypertension. Patients in this group present with at least one of the following: clinical hypersplenism, platelet count < 150,000/ml, or a history of high-risk/bleeding gastrointestinal varices. All included participants are individuals who were either not eligible for, or unwilling to undergo, standard surgical options (such as the Meso-Rex bypass) and have undergone percutaneous portal vein recanalization (PVR) as part of their routine clinical care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric patients treated at the ASST Papa Giovanni XXIII hospital in Bergamo, Italy (specifically identified through the Radiology 1, Pediatric Hematology, and Pediatric Surgery units). The study population comprises individuals who underwent percutaneous recanalization for non-cirrhotic extrahepatic portal vein obstruction between January 1, 2022, and November 30, 2026, and are currently undergoing routine clinical and radiological follow-up.
Key inclusion criteria (3 listed)
- < 18-year-old patients (with exception of patients > 17-year-old if they had a history of non-cirrhotic EHPVO since infancy)
- Portal hypertension resulting from non-cirrhotic EHPVO defined by the presence of at least one of the following: clinical hypersplenism; platelet count < 150,000 platelets per microliter; history of high risk or bleeding gastrointestinal varices
- Patients not eligible for, or not willing to undergo Meso-Rex bypass surgery
Key exclusion criteria (3 listed)
- Primary hepatocellular disease (infectious or any other)
- Any technical contraindication to PVR
- Histology proven fibrosis/cirrhosis (clinically significant >=F2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Portal Vein Recanalization (PVR)Also: Portal Vein RecanalizationIntervention Description: Percutaneous portal vein recanalization (PVR) is a minimally invasive endovascular procedure performed via interventional radiology to restore portal blood flow in pediatric patients with non-cirrhotic extrahepatic portal vein obstruction (EHPVO). The procedure utilizes catheter-based techniques, consisting of balloon angioplasty alone or combined with endovascular stent placement, tailored to individual anatomy. Unlike traditional surgical options (such as Meso-Rex bypass) or non-physiological shunts, PVR re-establishes portal perfusion directly into the native hepatic circulation via a percutaneous route for patients ineligible for or unwilling to undergo surgery. The intervention also includes post-procedural antithrombotic medical therapy. Patients who failed PVR are investigated for alternative treatment strategies including: trans jugular intrahepatic portosystemic shunt (TIPS), Meso-Rex bypass (MRB) and surgical shunts. | Procedure or surgery | Children with non-cirrhotic extrahepatic portal vein Obstruction |
Primary outcome
Change of Hematologic Parameters
Time frame: up to 36 months
Evaluation of change from baseline in Red Blood Cell (RBC), White Blood Cell (WBC) and Platelet counts, evaluated at 6,12,24 and 36 month post PVR
Status of Esophagogastric Varices
Time frame: up to 36 months
Assessment of changes in esophagogastric varices during follow-up upper gastrointestinal endoscopy.
Change in Spleen Stiffness
Time frame: up to 36 months
Assessment of the change in spleen stiffness measured by shear wave elastography (SWE) compared to baseline values.
Change in Spleen Diameter
Time frame: up to 36 months
Evaluation of changes in spleen longitudinal diameter relative to age-specific normal ranges and baseline measurements over time.
Incidence of Gastrointestinal Bleeding Events
Time frame: up to 36 monts
Assessment of the occurrence or recurrence of gastrointestinal bleeding episodes during the observation period.
7 secondary outcomes
Rate of Technical Success
Time frame: Up to 36 months post-procedure
Portal Vein Patency Rate
Time frame: up to 36 months post-procedures
Incidence of Portal Vein Reocclusion
Time frame: up to 36 months post-procedures
Diagnostic Accuracy of Spleen SWE
Time frame: up to 36 month post-procedures
Rate of Procedure-Related Complications
Time frame: up to 36 months post-procedures
Radiation and Contrast Exposure
Time frame: up to 36 months post-procedures
Comparative Outcomes by Technique
Time frame: up to 36 months post-procedures
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 14 Oct 2026.
- Results publication: PubMed 40105912Martins de Mattos KD, Marra P, Carbone FS, Muglia R, Dulcetta L, Fagiuoli S, D'Antiga L, Sironi S. Non-anatomical revascularization of the portal vein in children with non-cirrhotic extrahepatic portal vein obstruction. Pediatr Radiol. 2025 May;55(6):1308-1312. doi: 10.1007/s00247-025-06218-1. Epub 2025 Mar 19.
- Results publication: PubMed 39242398Marra P, Franchi-Abella S, Hernandez JA, Ronot M, Muglia R, D'Antiga L, Sironi S. Percutaneous recanalization of non-cirrhotic extrahepatic portal vein obstruction in children: technical considerations in a preliminary cohort. Eur Radiol. 2025 Jun;35(6):3262-3269. doi: 10.1007/s00330-024-11040-8. Epub 2024 Sep 6.
- Results publication: PubMed 41910605Marra P, Franchi-Abella S, Sironi S. Portal Vein Recanalization in Children: Expanding Physiological Restoration Beyond the Meso-Rex Bypass. Cardiovasc Intervent Radiol. 2026 Mar 30. doi: 10.1007/s00270-026-04419-1. Online ahead of print. No abstract available.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension, Portal and Interventional Radiology, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Hematologic Parameters (time frame: up to 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07873021, which also lists 3 linked publications.
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 14 Oct 2026.