3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation

Portal Hypertension Clinical Trial

Official title:

Guidance for TIPS Creation: CT-image Versus CO2 Portography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02480426
• Other study ID #: CT-overlay
• Status: Not yet recruiting
• Phase: N/A
• First received: June 21, 2015
• Last updated: June 23, 2015
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography during transjugular intrahepatic portosystemic shunt (TIPS) creation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Cirrhosis

2. Scheduled for indicated TIPS procedure

Exclusion Criteria:

1. Presence of portal vein thrombosis

2. Presence of ascites

3. Presence of hepatic vein occlusion or stenosis

4. Proven malignancy including hepatocellular carcinoma 5. End-stage renal disease under renal replacement therapy; 6. Cardiorespiratory failure 7. Pregnancy or patients not giving informed consent for TIPS procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension, Portal
• Portal Hypertension

Intervention

Device:
• CT-image guidance
TIPS creation is performed under the guidance of 3D CT-image.

Drug:
• CO2 portograms guidance
TIPS creation is performed under the guidance of two-dimensional (2D) CO2 portograms.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success rate		procedure	No
Secondary	Median needle passes for portal vein entry		procedure	No
Secondary	Median radiographic fluoroscopy time for portal vein entry		procedure	No
Secondary	The median radiation dose for the whole TIPS procedure		procedure	No
Secondary	The rate of TIPS complication		6 months	Yes