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

Not Applicable

• Conditions: Portal Vein, Cavernous Transformation Of; Hypertension, Portal
• Interventions: 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

• Registration Number: NCT02504034
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Status Verified: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-20
• Last Update Submitted: 2015-07-20
• Study First Posted: 2015-07-21
• Last Update Posted: 2015-07-21
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transhepatic portosystemic shunt	6-French sheath	Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Transhepatic portosystemic shunt	22-gauge chiba needle	Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Transhepatic portosystemic shunt	260-cm-long stiff shaft wire	Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Transhepatic portosystemic shunt	Bare metal stent	Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Transhepatic portosystemic shunt	Transhepatic portosystemic shunt	Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Transhepatic portosystemic shunt	Covered stent	Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment
Transhepatic portosystemic shunt	Balloon catheter	Patients with cavernous transformation of portal vein undergo transhepatic portalsystemic shunt and other interventional radiology treatment

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Radiology; 🇨🇳 Guangzhou, Guangdong, China