An interventional study of Portal Vein Recanalization and Stenting in Extrahepatic Portal Vein Obstruction (EHPVO), sponsored by Ain Shams University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
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.
Time frame: Intraoperative and during the 6-month follow-up period
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Evaluated throughout the 6 months follow up period
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Oct 2027, 24 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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