NCT02480426

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

June 21, 2015

Last Update Submit

June 23, 2015

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (1)

  • Technical success rate

    procedure

Secondary Outcomes (4)

  • 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

Study Arms (2)

CT-image guidance

EXPERIMENTAL

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

CO2 portography

ACTIVE COMPARATOR

two two-dimensional (2D) CO2 portograms

Drug: CO2 portograms guidance

Interventions

CT-image guidanceDEVICE

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

CT-image guidance
CO2 portograms guidanceDRUG

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

CO2 portography

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis
  • Scheduled for indicated TIPS procedure

You may not qualify if:

  • Presence of portal vein thrombosis
  • Presence of ascites
  • Presence of hepatic vein occlusion or stenosis
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 21, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06