Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy

Hypertension, Portal Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02505152
• Other study ID #: PTIPSDORNO3HSYSU
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2015
• Last updated: November 10, 2015
• Start date: October 2010

Study information

• Verified date: November 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: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with portal hypertension who have the history of splenectomy and have enough image information to confirm occlusion 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:
• Percutaneous transhepatic intrahepatic portosystemic shunt
Under fluoroscopic guidance, 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 7-French sheath inserted over the wire. Then retrohepatic inferior vena cava(RIVC) or hepatic vein(HV) was punctured with a 20-gauge, 30-cm Chiba needle through 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 stiff shaft wire was then introduced through the transjugular sheath and manipulated into main portal vein(MPV) and then into superior mesenteric vein(SMV). Afterward the PTIPS procedure was completed in the standard transjugular fashion.

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	No gastrointestinal rebleeding in 1 month after interventions	No gastrointestinal rebleeding in 1 month after interventions	1 month	Yes
Primary	Ascites disappear in 1 month after interventions	Ascites disappear in 1 month after interventions	1 month	Yes
Secondary	Whether the shunt is patent after interventions in 6 months	Patent shunt in 6 months after interventions proved by US or CT	6 months	Yes