3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation

Guidance for TIPS Creation: CT-image Versus CO2 Portography

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

Study Overview

• Status: Unknown
• Conditions: Portal Hypertension
• Intervention / Treatment: Device: CT-image guidance; Drug: CO2 portograms guidance

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-image guidance; Previously acquired portal venous phase of CT datasets and intra-operative CT datasets were registered on a dedicated workstation. The selected volume of interest of the CT-image showing portal vein vasculature was overlaid onto the fluoroscopic display as real-time 3D CT-image guidance during the procedure.	Device: CT-image guidance; TIPS creation is performed under the guidance of 3D CT-image.
Active Comparator: CO2 portography; two two-dimensional (2D) CO2 portograms	Drug: CO2 portograms guidance; TIPS creation is performed under the guidance of two-dimensional (2D) CO2 portograms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Technical success rate	procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Median needle passes for portal vein entry	procedure
Median radiographic fluoroscopy time for portal vein entry	procedure
The median radiation dose for the whole TIPS procedure	procedure
The rate of TIPS complication	6 months

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: June 21, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hypertension, Portal
• Other Study ID Numbers: CT-overlay