NeoplasmsNCT05519618
Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus
An observational study of Neoplasms and Spine Tumor, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Vertebra is one of the most common site of metastatic disease, which may cause severe pain or neurological deficit. Debulking surgery usually has better local control and survival benefit as compared with decompression or radiotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms, Spine Tumor, Venous Hypertension
- What is being tested?
- Epidural veins pressure and flow measurement
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 31 Jul 2023
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who are suspected to have spine tumor, and referred to the multi-discipline spine oncology team in the study institute, for evaluation of debulking surgery or en bloc resection of the spinal tumor.
Who may be able to join
- Patient who receive pre-operative angiography and possible embolization before debulking surgery or en bloc resection of the spinal tumor.
- The tumor has to be located in thoracic or lumbar spine.
Who cannot join
- Confirmed non-tumor diagnosis.
- Patient who cannot tolerate the procedure due to severe pain.
- Patients who cannot receive angiography or embolization due to contraindications, including poor renal function (Serum creatinine >2.0 deciliter/mg or estimated glomerular filtration rate(eGFR)) < 30ml/min) , severe allergy to contrast medium, uncorrectable coagulopathy and bleeding diathesis.
- Patient who has severe neurological deficit that should receive emergent decompression.
- Poor image quality.
- Expected life expectancy < 6 months.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
YuCheng Huang, M.D., +886223123456 ext. 262570, squll1peter@gmail.com
About this study
Vertebra is one of the most common site of metastatic disease, which may cause severe pain or neurological deficit. Debulking surgery usually has better local control and survival benefit as compared with decompression or radiotherapy. However, debulking surgery often accompany with massive blood loss, which may cause hemorrhagic shock or death. The major bleeding point during operation including tumor parenchyma, arteries that are difficult to ligate, and epidural venous plexus. Vascularity of tumor parenchyma had been associated with increased intraoperative blood loss, on the other hand, there is a lack in the literature regarding to evaluation of the size, flow and pressure of epidural venous plexus, and their changes after embolization.
- Conditions
- Neoplasms, Spine Tumor, Venous Hypertension
- Being tested
- Epidural veins pressure and flow measurement
- Keywords
- Spine tumor, Venous pressure, Internal vertebral venous plexus, Epidural venous plexus
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural veins pressure and flow measurementProcedure or surgery
The purpose of this study is to measure to pressure and flow of epidural venous plexus.
The procedure will be performed alongside during pre-operative embolization at the angiography suite.
It will be performed under general anesthesia. A the start of the procedure, a venous access will be established at the inguinal region. Co-axial catheters will be navigated to epidural venous plexus under the guidance of fluoroscopy. After the placement of catheter, the pressure and flow of epidural venous plexus will be measured at three time points: 1. Right after catheter reach the targeted location 2. Right before embolization. 3. After embolization. The participant will be instructed to control their breathe during measurement.
After measurement, the catheter will be removed alongside with embolization devices, and achieved hemostasis as routine.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Patient planned to receive debulking or en bloc resection of vertebral tumor. Receives: Procedure: Epidural veins pressure and flow measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural venous pressure
Epidural venous pressure measured with pressure wire after reach the targeted location, before embolization and after embolization during the embolization procedure.
Measured: During the embolization intervention.
Epidural venous flow rate.
Epidural venous flow rate measured with fluoroscopy after reach the targeted location, before embolization and after embolization during the embolization procedure.
Measured: During the embolization intervention.
Secondary outcomes (1)
Size of epidural venous plexus.
Measuring the size of epidural venous plexus with fluoroscopy after reach the targeted location, before embolization and after embolization during the embolization procedure.
Measured: During the embolization intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- YuCheng Huang, M.D., Principal investigator, Department of Radiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519618
- Sponsor's protocol ID
- 202112207RINC
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus
- ClinicalTrials.gov ID
- NCT05519618
- Acronym / sponsor ID
- 202112207RINC
- Conditions
- Neoplasms, Spine Tumor, Venous Hypertension
- Keywords
- Spine tumor, Venous pressure, Internal vertebral venous plexus, Epidural venous plexus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 29 Aug 2022 (actual)
- 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.
Vertebra is one of the most common site of metastatic disease, which may cause severe pain or neurological deficit. Debulking surgery usually has better local control and survival benefit as compared with decompression or radiotherapy. However, debulking surgery often accompany with massive blood loss, which may cause hemorrhagic shock or death. The major bleeding point during operation including tumor parenchyma, arteries that are difficult to ligate, and epidural venous plexus. Vascularity of tumor parenchyma had been associated with increased intraoperative blood loss, on the other hand, there is a lack in the literature regarding to evaluation of the size, flow and pressure of epidural venous plexus, and their changes after embolization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Procedure: Epidural veins pressure and flow measurementPatient planned to receive debulking or en bloc resection of vertebral tumor. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who are suspected to have spine tumor, and referred to the multi-discipline spine oncology team in the study institute, for evaluation of debulking surgery or en bloc resection of the spinal tumor.
Key inclusion criteria (2 listed)
- Patient who receive pre-operative angiography and possible embolization before debulking surgery or en bloc resection of the spinal tumor.
- The tumor has to be located in thoracic or lumbar spine.
Key exclusion criteria (6 listed)
- Confirmed non-tumor diagnosis.
- Patient who cannot tolerate the procedure due to severe pain.
- Patients who cannot receive angiography or embolization due to contraindications, including poor renal function (Serum creatinine >2.0 deciliter/mg or estimated glomerular filtration rate(eGFR)) < 30ml/min) , severe allergy to contrast medium, uncorrectable coagulopathy and bleeding diathesis.
- Patient who has severe neurological deficit that should receive emergent decompression.
- Poor image quality.
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 |
|---|---|---|
| Epidural veins pressure and flow measurementThe purpose of this study is to measure to pressure and flow of epidural venous plexus. The procedure will be performed alongside during pre-operative embolization at the angiography suite. It will be performed under general anesthesia. A the start of the procedure, a venous access will be established at the inguinal region. Co-axial catheters will be navigated to epidural venous plexus under the guidance of fluoroscopy. After the placement of catheter, the pressure and flow of epidural venous plexus will be measured at three time points: 1. Right after catheter reach the targeted location 2. Right before embolization. 3. After embolization. The participant will be instructed to control their breathe during measurement. After measurement, the catheter will be removed alongside with embolization devices, and achieved hemostasis as routine. | Procedure or surgery | Participants |
Primary outcome
Epidural venous pressure
Time frame: During the embolization intervention.
Epidural venous pressure measured with pressure wire after reach the targeted location, before embolization and after embolization during the embolization procedure.
Epidural venous flow rate.
Time frame: During the embolization intervention.
Epidural venous flow rate measured with fluoroscopy after reach the targeted location, before embolization and after embolization during the embolization procedure.
1 secondary outcome
Size of epidural venous plexus.
Time frame: During the embolization intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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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.
YuCheng Huang, M.D. principal investigator
Department of Radiology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Spine Tumor, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact YuCheng Huang, M.D. (+886223123456 ext. 262570, squll1peter@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidural venous pressure (time frame: During the embolization intervention.). The study lists 2 primary outcomes in all. 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 29 Aug 2022.