3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation

NCT ID: NCT02480426

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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Conditions

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Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CT-image guidance

Intervention Type DEVICE

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

CO2 portography

two two-dimensional (2D) CO2 portograms

Group Type ACTIVE_COMPARATOR

CO2 portograms guidance

Intervention Type DRUG

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

Interventions

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CT-image guidance

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

Intervention Type DEVICE

CO2 portograms guidance

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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luo xuefeng

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CT-overlay

Identifier Type: -

Identifier Source: org_study_id

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