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

Hypertension, Portal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02504034
• Other study ID #: DORNO3HSYSU
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2015
• Last updated: July 20, 2015
• Start date: October 2010

Study information

• Verified date: July 2015
• Source: Sun Yat-sen University
• Contact: Zaibo Jiang, MD.
• Phone: +86 020 85252066
• Email: jiangzaibo[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: The Ethics Committee of The Third Affiliated Hospital of Sun Yat-Sen University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Portal Vein, Cavernous Transformation Of

Intervention

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

• 22-gauge chiba needle

• 260-cm-long stiff shaft wire

• Balloon catheter

• Bare metal stent

• Covered stent

Locations

Country	Name	City	State
China	Department of Radiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Gastrointestinal Bleeding	No gastrointestinal bleeding proved by patients' symptoms (If the patients had the history of gastrointestinal bleeding before)	1 month	Yes
Primary	Ascites Volume (mL)	No ascites proved by CT scanning or ultrasound (If the patients had the history of ascites before)	1 month	Yes