Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein

Study Overview
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Brief Summary
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To evaluate the values of portosystemic shunt and other interventional radiology approaches for treatment of symptomatic portal hypertension in patients with cavernous transformation of portal vein.

Official Title
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Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein

Conditions
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Portal Vein, Cavernous Transformation Of, Hypertension, Portal

Intervention / Treatment
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* Procedure: Transhepatic portosystemic shunt
* Device: 6-French sheath
* Device: 22-gauge chiba needle
* Device: 260-cm-long stiff shaft wire
* Device: Balloon catheter
* Device: Bare metal stent
* Device: Covered stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with portal hypertention who have enough image information to confirm cavernous transformation of portal vein. Exclusion Criteria: Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transhepatic portosystemic shunt<br>Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment | Procedure: Transhepatic portosystemic shunt<br>* Portal vein (PV) was punctured with a 22-gauge chiba needle. A 0.018-inch guidewire was advanced through the needle into PV lumen. The needle was exchanged and a 6-French sheath inserted over the wire. Then middle hepatic vein (MHV) was punctured with a 20-gauge reformed needle through the transhepatic sheath. Another 0.018-inch guidewire was advanced through the needle into right internal jugular vein and then snared out of body. A 0.035-inch, 260-cm-long stiff shaft wire was introduced through the transjugular sheath and manipulated into main portal vein (MPV) and then into SMV. The parenchymal tract was dilated with balloon catheter, then one or more bare metal stents and one or more covered stents were inserted to line the parenchymal tract.<br>Device: 6-French sheath<br> <br> Device: 22-gauge chiba needle<br> <br> Device: 260-cm-long stiff shaft wire<br> <br> Device: Balloon catheter<br> <br> Device: Bare metal stent<br> <br> Device: Covered stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Gastrointestinal Bleeding | No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before) | 1 month | 
| Ascites Volume (mL) | No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Portal Vein, Cavernous Transformation Of, Hypertension, Portal, Radiology, Interventional, Portalsystemic shunt