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Trial Title:
Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus
NCT ID:
NCT05519618
Condition:
Neoplasms
Spine Tumor
Venous Hypertension
Conditions: Official terms:
Hypertension
Conditions: Keywords:
Spine tumor
Venous pressure
Internal vertebral venous plexus
Epidural venous plexus
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Epidural veins pressure and flow measurement
Description:
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.
Arm group label:
Participants
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. 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Patient who receive pre-operative angiography and possible embolization before
debulking surgery or en bloc resection of the spinal tumor.
2. The tumor has to be located in thoracic or lumbar spine.
Exclusion Criteria:
1. Confirmed non-tumor diagnosis.
2. Patient who cannot tolerate the procedure due to severe pain.
3. 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.
4. Patient who has severe neurological deficit that should receive emergent
decompression.
5. Poor image quality.
6. Expected life expectancy < 6 months.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
YuCheng Huang, M.D.
Phone:
+886223123456
Phone ext:
262570
Email:
squll1peter@gmail.com
Start date:
August 1, 2022
Completion date:
July 31, 2023
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
Ministry of Science and Technology, Taiwan
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519618
