NCT05519618|Unknown
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Sponsor study identifier
observational
32
1 country
1
Study Start
August 1, 2022
Actual (reported)Primary Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2022
Actual (reported)August 23, 2022
Actual (reported)August 29, 2022
Actual (reported)July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Size of epidural venous plexus.
During the embolization intervention.
Patient planned to receive debulking or en bloc resection of vertebral tumor.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
National Taiwan University Hospital
Taipei, 100, Taiwan
YuCheng Huang, M.D.
Department of Radiology, National Taiwan University Hospital
First Submitted
August 23, 2022
First Posted
August 29, 2022
Study Start
August 1, 2022
Actual (reported)Primary Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Nurse-Led Electronic Patient-Reported Outcome System to Improve Quality of Life in Chemotherapy Patients
Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
Contact the study team to confirm eligibility.
Study Completion
July 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 29, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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