Radiological Intervention for Childhood Extra-Hepatic Portal Vein Obstruction

NCT07867587 | Enrolling By Invitation

• 1 other identifier: EHPVO-PEDS-ASU-2026
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 obstruction (EHPVO). The trial will assess technical feasibility, patency rates, and the reduction of complications such as variceal bleeding, ascites, and thrombocytopenia.

Conditions

Extrahepatic Portal Vein Obstruction (EHPVO)

Keywords

EHPVO

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative and during the 6-month follow-up period

Secondary Outcomes (4)

• Post Procedural Incidence of Variceal bleeding Episodes

  Evaluated throughout the 6-month follow-up period

• Improvement in Hypersplenism Related Cytopenia and Thrombocytopenias

  Evaluated throughout the 6 months follow up period

• Resolution or Reduction Rate of Ascites

  Evaluated throughout the 6 months follow up period

• Rate of Complication-Free Clinical Recovery

  Evaluated throughout the 6 months follow up period

Study Arms (1)

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.

Device: Portal Vein Recanalization and Stenting

Interventions

Portal Vein Recanalization and Stenting DEVICE

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

Radiological intervention: portal vein recanalization

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Pre-existing liver disease.
• Other causes of portal hypertension.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11566, Egypt

Location

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: October 9, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-09

Locations

EG (1)