Surgery Clinical Trial
Official title:
Using CT-DSA With Deformable Registration Technique to Predict Efficacy in Preoperative Embolization for Spinal Metastasis
Vertebra is one of the most common site of metastatic disease, which may cause severe pain or
neurological deficit. Decompressive surgery or radiation therapy are of limited efficacy and
recurrence is very likely. Debulking surgery usually has better local control and survival
benefit. However, debulking surgery often accompany with massive blood loss, which may cause
hemorrhagic shock or death. It is known that intraoperative blood loss is associated with
tumoral vascularity. However, there is current no objective method to evaluate vascularity
status. On the other hand, preoperative embolization is considered as major method to
decrease blood loss. There is also objective method to evaluate the embolization effect. By
our innovative dual energy computed tomography angiography - digital subtraction angiography
(CT-DSA), the tumoral vascularity status and embolization effect of spinal tumor can be
objectively assessed. We aim to utilize CT-DSA to investigate spinal tumor, in a hope to find
out correlation of vascularity status, embolization method, and surgical outcome, which can
help individual disease status and tailored treatment decision.
Key word: spine/embolization/computed tomography
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 29, 2021 |
Est. primary completion date | March 29, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient with clinical diagnosis for thoracolumbar vertebral primary or metastatic malignancy 2. Eligible for aggressive spinal surgery, including debulking and en bloc spondylectomy 3. Life expectancy more than 6 months 4. Serum creatinine less than 1.5 mg/dL Exclusion Criteria: 1. Age less than 20 year old 2. Woman in pregnancy or breast feeding 3. Serious allergic reaction to contrast medium 4. Instable neurological condition warrant urgent operation |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | estimated blood loss during surgery | blood lose in debulking spinal surgery | 24 hours | |
Secondary | transfusion amount | perioperative blood transfusion | 24 hours |
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