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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Spine Tumor; Venous Hypertension
• Intervention / Treatment: Procedure: Epidural veins pressure and flow measurement

• Study Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

• Study Contact: Name: YuCheng Huang, M.D.; Phone Number: 262570 +886223123456; Email: squll1peter@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: YuCheng Huang, M.D.; Phone Number: 262570 +886223123456; Email: squll1peter@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: YuCheng Huang, M.D., Department of Radiology, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Venous pressure; Spine tumor; Internal vertebral venous plexus; Epidural venous plexus
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 202112207RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No