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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02504034

Collaborator

(none)

150

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Portal Vein, Cavernous Transformation Of Hypertension, Portal	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transhepatic portosystemic shunt Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment	Procedure: 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. 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

Arm

Intervention/Treatment

Experimental: Transhepatic portosystemic shunt

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

Procedure: 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.

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

Outcome Measures

Primary Outcome Measures

Incidence Rate of Gastrointestinal Bleeding [1 month]
No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before)
Ascites Volume (mL) [1 month]
No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiology	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Study Chair: Zaibo Jiang, MD., Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02504034

Other Study ID Numbers:

DORNO3HSYSU

First Posted:

Jul 21, 2015

Last Update Posted:

Jul 21, 2015

Last Verified:

Jul 1, 2015

Keywords provided by Zaibo Jiang, Department of Radiology, The Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University

Portal Vein, Cavernous Transformation Of

Hypertension, Portal

Radiology, Interventional

Portalsystemic shunt

Additional relevant MeSH terms:

Hypertension, Portal

Hypertension

Study Results

No Results Posted as of Jul 21, 2015