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

NCT05519618 | Unknown

• 1 other identifier: 202112207RINC
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Spine Tumor; Venous Hypertension

Keywords

Spine tumor; Venous pressure; Internal vertebral venous plexus; Epidural venous plexus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Size of epidural venous plexus.

  During the embolization intervention.

Study Arms (1)

Participants

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

Procedure: Epidural veins pressure and flow measurement

Interventions

Epidural veins pressure and flow measurement 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.

Participants

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient who receive pre-operative angiography and possible embolization before debulking surgery or en bloc resection of the spinal tumor.
• The tumor has to be located in thoracic or lumbar spine.

You may not qualify if:

• Confirmed non-tumor diagnosis.
• Patient who cannot tolerate the procedure due to severe pain.
• 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.
• Patient who has severe neurological deficit that should receive emergent decompression.
• Poor image quality.
• Expected life expectancy \< 6 months.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• YuCheng Huang, M.D.

  Department of Radiology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YuCheng Huang, M.D.

CONTACT

+886223123456; squll1peter@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 29, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

TW (1)