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

NCT ID: NCT02504034

Last Updated: 2015-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

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.

Detailed Description

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Conditions

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Portal Vein, Cavernous Transformation Of Hypertension, Portal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transhepatic portosystemic shunt

Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment

Group Type EXPERIMENTAL

Transhepatic portosystemic shunt

Intervention Type PROCEDURE

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.

6-French sheath

Intervention Type DEVICE

22-gauge chiba needle

Intervention Type DEVICE

260-cm-long stiff shaft wire

Intervention Type DEVICE

Balloon catheter

Intervention Type DEVICE

Bare metal stent

Intervention Type DEVICE

Covered stent

Intervention Type DEVICE

Interventions

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Transhepatic portosystemic shunt

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.

Intervention Type PROCEDURE

6-French sheath

Intervention Type DEVICE

22-gauge chiba needle

Intervention Type DEVICE

260-cm-long stiff shaft wire

Intervention Type DEVICE

Balloon catheter

Intervention Type DEVICE

Bare metal stent

Intervention Type DEVICE

Covered stent

Intervention Type DEVICE

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zaibo Jiang

Department of Radiology, The Third Affiliated Hospital, Sun Yat-Sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zaibo Jiang, MD.

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

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Department of Radiology

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zaibo Jiang, MD.

Role: CONTACT

+86 020 85252066

Facility Contacts

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Zaibo Jiang, MD.

Role: primary

+86 020 85252066

Other Identifiers

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DORNO3HSYSU

Identifier Type: -

Identifier Source: org_study_id

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