Extrahepatic Portal Vein Obstruction (EHPVO)NCT07867587
Radiological Intervention for Childhood Extra-Hepatic Portal Vein Obstruction
A study testing Portal Vein Recanalization and Stenting in people with Extrahepatic Portal Vein Obstruction (EHPVO), run by Ain Shams University at 1 site in Egypt.
Trial summary
This study evaluates the safety and effectiveness of percutaneous portal vein recanalization (PVR) with stent placement, with or without transjugular intrahepatic portosystemic shunt (TIPS), in restoring portal flow and improving clinical outcomes in children and adolescents with chronic extrahepatic portal vein… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Extrahepatic Portal Vein Obstruction (EHPVO)
- What is being tested?
- Portal Vein Recanalization and Stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2025to 30 Oct 2027
- Phase
- Interventional
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients (aged < 17 years) diagnosed with chronic extrahepatic portal vein obstruction (EHPVO) without cirrhosis.
- Presence of refractory portal hypertension complications (e.g., recurrent variceal bleeding, symptomatic hypersplenism/thrombocytopenia, or refractory ascites) or portal cavernoma cholangiopathy
Who cannot join
- Pre-existing liver disease.
- Other causes of portal hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Radiological Intervention for Chronic Extra-Hepatic Portal Vein Obstruction in Children and Adolescents: Technical Feasibility and Early Clinical Outcome.
This study evaluates the safety and effectiveness of percutaneous portal vein recanalization (PVR) with stent placement, with or without transjugular intrahepatic portosystemic shunt (TIPS), in restoring portal flow and improving clinical outcomes in children and adolescents with chronic extrahepatic portal vein obstruction (EHPVO). The trial will assess technical feasibility, patency rates, and the reduction of complications such as variceal bleeding, ascites, and thrombocytopenia.
Read the detailed description
This pilot, one-arm interventional study aims to evaluate all pediatric patients till the end of one year study duration below 17 years old age presenting with chronic EHPVO and refractory complications (such as recurrent gastrointestinal bleeding, refractory ascites, or portal cavernoma cholangiopathy).
All enrolled patients undergo pre-procedure clinical evaluation, laboratory profiles, upper gastrointestinal endoscopy, and advanced imaging including Doppler ultrasound and CT portography. The interventional procedure involves percutaneous portal vein recanalization and stenting, with or without TIPS, performed using a multi-access strategy (trans-splenic and/or trans-hepatic approaches) under general anesthesia by an expert interventional radiologists. Post-procedure management includes targeted antibiotic therapy, structured anticoagulation protocols, and a longitudinal follow-up schedule tracking clinical parameters, laboratory indices, Doppler patency, 3-month CT portography, and follow-up endoscopy. Complications are systematically recorded and graded using the Modified CIRSE Classification System.
- Being tested
- Portal Vein Recanalization and Stenting
- Keywords
- EHPVO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal Vein Recanalization and StentingDevice
Percutaneous portal vein recanalization and stenting using metallic uncovered stents, with or without TIPS, performed using a multi-access strategies (access needles, guidewires and catheters) under general anesthesia to restore portal flow
| Study group | Role | What they receive |
|---|---|---|
| Radiological intervention: portal vein recanalization | Experimental | Pediatric patients with chronic EHPVO undergo percutaneous portal vein recanalization and stenting, with or without TIPS, using a multi-access approach under general anesthesia. Receives: Device: Portal Vein Recanalization and Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate and Primary Portal Vein Patency Assessed by Doppler Ultrasound
Evaluated by the technical feasibility of successful guidewire passage across the chronic occlusion, stent deployment, and immediate intraoperative restoration of hepatopetal portal flow (confirmed by angiography), as well as the maintenance of stent patency assessed via Doppler ultrasound during the 6-month follow-up.
Measured: Intraoperative and during the 6-month follow-up period
Secondary outcomes (4)
Post Procedural Incidence of Variceal bleeding Episodes
Assessment of the frequency and prevention of variceal bleeding episodes after the interventional procedure over the follow up period
Measured: Evaluated throughout the 6-month follow-up period
Improvement in Hypersplenism Related Cytopenia and Thrombocytopenias
Assessment of the improvement in blood counts, specifically the platelets count
Measured: Evaluated throughout the 6 months follow up period
Resolution or Reduction Rate of Ascites
Evaluation of the regression, resolution, or reduction of ascites volume following the procedure
Measured: Evaluated throughout the 6 months follow up period
Rate of Complication-Free Clinical Recovery
Assessment of clinical recovery and freedom from major complications (such as procedural failure, re-thrombosis, infection, or worsening of portal hypertension symptoms) indicating overall clinical stabilization
Measured: Evaluated throughout the 6 months follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Oct 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic Portal Vein Obstruction (EHPVO)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867587
- Sponsor's protocol ID
- EHPVO-PEDS-ASU-2026
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Intervention for Chronic Extra-Hepatic Portal Vein Obstruction in Children and Adolescents: Technical Feasibility and Early Clinical Outcome.
- ClinicalTrials.gov ID
- NCT07867587
- Acronym / sponsor ID
- EHPVO-PEDS-ASU-2026
- Keywords
- EHPVO
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 9 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 study evaluates the safety and effectiveness of percutaneous portal vein recanalization (PVR) with stent placement, with or without transjugular intrahepatic portosystemic shunt (TIPS), in restoring portal flow and improving clinical outcomes in children and adolescents with chronic extrahepatic portal vein obstruction (EHPVO). The trial will assess technical feasibility, patency rates, and the reduction of complications such as variceal bleeding, ascites, and thrombocytopenia.
Detailed description
This pilot, one-arm interventional study aims to evaluate all pediatric patients till the end of one year study duration below 17 years old age presenting with chronic EHPVO and refractory complications (such as recurrent gastrointestinal bleeding, refractory ascites, or portal cavernoma cholangiopathy).
All enrolled patients undergo pre-procedure clinical evaluation, laboratory profiles, upper gastrointestinal endoscopy, and advanced imaging including Doppler ultrasound and CT portography. The interventional procedure involves percutaneous portal vein recanalization and stenting, with or without TIPS, performed using a multi-access strategy (trans-splenic and/or trans-hepatic approaches) under general anesthesia by an expert interventional radiologists. Post-procedure management includes targeted antibiotic therapy, structured anticoagulation protocols, and a longitudinal follow-up schedule tracking clinical parameters, laboratory indices, Doppler patency, 3-month CT portography, and follow-up endoscopy. Complications are systematically recorded and graded using the Modified CIRSE Classification System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiological intervention: portal vein recanalization | Experimental | Device: Portal Vein Recanalization and StentingPediatric patients with chronic EHPVO undergo percutaneous portal vein recanalization and stenting, with or without TIPS, using a multi-access approach under general anesthesia. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients (aged < 17 years) diagnosed with chronic extrahepatic portal vein obstruction (EHPVO) without cirrhosis.
- Presence of refractory portal hypertension complications (e.g., recurrent variceal bleeding, symptomatic hypersplenism/thrombocytopenia, or refractory ascites) or portal cavernoma cholangiopathy
Key exclusion criteria (2 listed)
- Pre-existing liver disease.
- Other causes of portal hypertension.
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 |
|---|---|---|
| Portal Vein Recanalization and StentingPercutaneous portal vein recanalization and stenting using metallic uncovered stents, with or without TIPS, performed using a multi-access strategies (access needles, guidewires and catheters) under general anesthesia to restore portal flow | Device | Radiological intervention: portal vein recanalization |
Primary outcome
Technical Success Rate and Primary Portal Vein Patency Assessed by Doppler Ultrasound
Time frame: Intraoperative and during the 6-month follow-up period
Evaluated by the technical feasibility of successful guidewire passage across the chronic occlusion, stent deployment, and immediate intraoperative restoration of hepatopetal portal flow (confirmed by angiography), as well as the maintenance of stent patency assessed via Doppler ultrasound during the 6-month follow-up.
4 secondary outcomes
Post Procedural Incidence of Variceal bleeding Episodes
Time frame: Evaluated throughout the 6-month follow-up period
Improvement in Hypersplenism Related Cytopenia and Thrombocytopenias
Time frame: Evaluated throughout the 6 months follow up period
Resolution or Reduction Rate of Ascites
Time frame: Evaluated throughout the 6 months follow up period
Rate of Complication-Free Clinical Recovery
Time frame: Evaluated throughout the 6 months follow up period
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 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Extrahepatic Portal Vein Obstruction (EHPVO)
Active, not recruitingObservational study
Percutaneous Portal Vein Recanalization for Refractory Portal Hypertension in Children With Non-Cirrhotic Extrahepatic Portal Vein Obstruction
Hypertension, Portal, Interventional Radiology
Not yet recruitingObservational study
Hematological Disorders in EHPVO Patients
Extrahepatic Portal Vein Obstruction (EHPVO), Thrombophilia
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.
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?
A study testing Portal Vein Recanalization and Stenting in people with Extrahepatic Portal Vein Obstruction (EHPVO), run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 20 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 Egypt. 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?
Technical Success Rate and Primary Portal Vein Patency Assessed by Doppler Ultrasound (time frame: Intraoperative and during the 6-month follow-up period). 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 20 Oct 2026.