Portal HypertensionNCT02480426
3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation
A study testing CT-image guidance and CO2 portograms guidance in people with Portal Hypertension, run by West China Hospital.
Trial summary
To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography during transjugular intrahepatic portosystemic shunt (TIPS) creation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- CT-image guidance and CO2 portograms guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis
- Scheduled for indicated TIPS procedure
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Portal Hypertension
- Being tested
- CT-image guidance, CO2 portograms guidance
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-image guidanceDevice
TIPS creation is performed under the guidance of 3D CT-image.
CO2 portograms guidanceDrug
TIPS creation is performed under the guidance of two-dimensional (2D) CO2 portograms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CT-image guidance |
| CO2 portography | Active comparator | two two-dimensional (2D) CO2 portograms Receives: Drug: CO2 portograms guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Measured: procedure
Secondary outcomes (4)
Median needle passes for portal vein entry
Measured: procedure
Median radiographic fluoroscopy time for portal vein entry
Measured: procedure
The median radiation dose for the whole TIPS procedure
Measured: procedure
The rate of TIPS complication
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luo xuefeng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480426
- Sponsor's protocol ID
- CT-overlay
- Status last verified
- Jun 2015
- First submitted
- 21 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guidance for TIPS Creation: CT-image Versus CO2 Portography
- ClinicalTrials.gov ID
- NCT02480426
- Acronym / sponsor ID
- CT-overlay
- Conditions
- Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography during transjugular intrahepatic portosystemic shunt (TIPS) creation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-image guidance | Experimental | Device: CT-image guidancePreviously 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. |
| CO2 portography | Active comparator | Drug: CO2 portograms guidancetwo two-dimensional (2D) CO2 portograms |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhosis
- Scheduled for indicated TIPS procedure
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-image guidanceTIPS creation is performed under the guidance of 3D CT-image. | Device | CT-image guidance |
| CO2 portograms guidanceTIPS creation is performed under the guidance of two-dimensional (2D) CO2 portograms. | Drug | CO2 portography |
Primary outcome
Technical success rate
Time frame: procedure
4 secondary outcomes
Median needle passes for portal vein entry
Time frame: procedure
Median radiographic fluoroscopy time for portal vein entry
Time frame: procedure
The median radiation dose for the whole TIPS procedure
Time frame: procedure
The rate of TIPS complication
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CT-image guidance and CO2 portograms guidance in people with Portal Hypertension, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.