CT-DSA Evaluation of Embolization in Debulking Spinal Surgery

NCT04497051 | Completed

• 1 other identifier: 202001028RINB
• Study Type: observational
• Target: 48
• 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. 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

Conditions

Spinal Metastases; Surgery

Keywords

vertebra; embolization; surgery

Outcome Measures

Primary Outcomes (1)

• estimated blood loss during surgery

  blood lose in debulking spinal surgery

  24 hours

Secondary Outcomes (1)

• transfusion amount

  24 hours

Study Arms (1)

Embolized patients

subjects receiving preoperative embolization for aggressive spinal debulking surgery

Diagnostic Test: CT-DSA

Interventions

CT-DSA DIAGNOSTIC_TEST

CTA before and after embolization

Embolized patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with clinical diagnosis for thoracolumbar vertebral malignancy who can receive preoperative emoblization

You may qualify if:

• Patient with clinical diagnosis for thoracolumbar vertebral primary or metastatic malignancy
• Eligible for aggressive spinal surgery, including debulking and en bloc spondylectomy
• Life expectancy more than 6 months
• Serum creatinine less than 1.5 mg/dL

You may not qualify if:

• Age less than 20 year old
• Woman in pregnancy or breast feeding
• Serious allergic reaction to contrast medium
• Instable neurological condition warrant urgent operation

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

• Yen-Heng Lin, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: August 18, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 24, 2024

Record last verified: 2023-03

Locations

TW (1)