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NCT07873021

Percutaneous Portal Vein Recanalization for Refractory Portal Hypertension in Children With Non-Cirrhotic Extrahepatic Portal Vein Obstruction

Sponsor: Papa Giovanni XXIII Hospital

View on ClinicalTrials.gov

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. 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.

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

33

Start Date

2022-01-01

Completion Date

2028-05-31

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

PROCEDURE

Percutaneous Portal Vein Recanalization (PVR)

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.

Locations (1)

ASST PAPA GIOVANNI XXIII - Piazza OMS-1, 24127 Bergamo

Bergamo, BG, Italy