Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus

Neoplasms Clinical Trial

Official title:

Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519618
• Other study ID #: 202112207RINC
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2022
• Source: National Taiwan University Hospital
• Contact: YuCheng Huang, M.D.
• Phone: +886223123456
• Email: squll1peter[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Neoplasms
• Spine Tumor
• Venous Hypertension

Intervention

Procedure:
• Epidural veins pressure and flow measurement
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidural venous pressure	Epidural venous pressure measured with pressure wire after reach the targeted location, before embolization and after embolization during the embolization procedure.	During the embolization intervention.
Primary	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.	During the embolization intervention.
Secondary	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.	During the embolization intervention.