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

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National Taiwan University

Status

Enrolling

Conditions

Spine Tumor
Venous Hypertension
Neoplasms

Treatments

Procedure: Epidural veins pressure and flow measurement

Study type

Observational

Funder types

Other

Identifiers

NCT05519618
202112207RINC

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

32 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

YuCheng Huang, M.D.

Data sourced from clinicaltrials.gov

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