An observational study in Hypertension, Portal, Interventional Radiology and Percutaneous Portal Vein Recanalization (PVR), sponsored by Papa Giovanni XXIII Hospital. Active, not recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Papa Giovanni XXIII Hospital · Observational
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.
345 studies on the registry are indexed under Hypertension, Portal; 110 are open to participants now.
This study's enrollment of 33 is below the median of 151 across 128 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →Papa Giovanni XXIII Hospital is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Also known as: Portal Vein Recanalization
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
Time frame: up to 36 months
Status of Esophagogastric Varices
Assessment of changes in esophagogastric varices during follow-up upper gastrointestinal endoscopy.
Time frame: 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.
Time frame: 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.
Time frame: up to 36 months
Incidence of Gastrointestinal Bleeding Events
Assessment of the occurrence or recurrence of gastrointestinal bleeding episodes during the observation period.
Time frame: up to 36 monts
Rate of Technical Success
Percentage of procedures achieving restoration of portal blood flow assessed by final procedural venography.
Time frame: 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.
Time frame: up to 36 months post-procedures
Incidence of Portal Vein Reocclusion
Frequency and patterns of portal vein reocclusion evaluated during follow-up.
Time frame: 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.
Time frame: up to 36 month post-procedures
Rate of Procedure-Related Complications
Incidence and severity of complications classified using CIRSE or Clavien-Dindo criteria.
Time frame: up to 36 months post-procedures
Radiation and Contrast Exposure
Cumulative volume of contrast agent and ionizing radiation exposure during the procedure.
Time frame: up to 36 months post-procedures
Comparative Outcomes by Technique
Comparison of outcomes between balloon angioplasty alone versus angioplasty with stent placement.
Time frame: up to 36 months post-procedures
Predictors of Technical Success and Complications
Evaluation of pre-procedural parameters associated with technical success and procedure-related complications to assess patient selection factors.
Time frame: Analyzed retrospectively over the study period (covering up to 36 months of follow-up per patient)
Cost-Effectiveness Analysis
Assessment of potential economic advantages for the healthcare system, focusing on re-hospitalization rates for acute events and the frequency of required endoscopic procedures.
Time frame: Analyzed retrospectively over the study period (covering up to 36 months of follow-up per patient)
Plan to share: Undecided
Started Jan 2022 (actual). Primary completion is estimated for Nov 2026, 58 months after the start.
Of 61 non-industry observational studies under Hypertension, Portal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 256. This study's planned 58 months is above that.
Counting every sponsor, half of 64 studies reached it within 43 months; a quarter within 30 and three quarters within 256.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Papa Giovanni XXIII Hospital