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

• Conditions: Venous Hypertension; Neoplasms; Spine Tumor
• Interventions: Procedure: Epidural veins pressure and flow measurement

• Registration Number: NCT05519618
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-01
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Study First Posted: 2022-08-29
• Last Update Posted: 2022-08-29
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Epidural veins pressure and flow measurement	Patient planned to receive debulking or en bloc resection of vertebral tumor.

Primary Outcome Measures

Name	Time	Method
Epidural venous pressure	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.	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.

Secondary Outcome Measures

Name	Time	Method
Size of epidural venous plexus.	During the embolization intervention.	Measuring the size of epidural venous plexus with fluoroscopy after reach the targeted location, before embolization and after embolization during the embolization procedure.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan