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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms Spine Tumor Venous Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

Patient planned to receive debulking or en bloc resection of vertebral tumor.

Epidural veins pressure and flow measurement

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No