3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation

Sichuan University

Status: Unknown

Conditions: Portal Hypertension

Treatments: Device: CT-image guidance; Drug: CO2 portograms guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT02480426

CT-overlay

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

CT-image guidance

Experimental group

Description:

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.

Treatment:

Device: CT-image guidance

CO2 portography

Active Comparator group

Description:

two two-dimensional (2D) CO2 portograms

Treatment:

Drug: CO2 portograms guidance