NCT05519618

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 32 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms
• Spine Tumor
• Venous Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-08-29
• Last updated: 2022-08-29

Locations

1 site across 1 country: Taiwan