Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Study Overview
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Brief Summary
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The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.

Official Title
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Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.

Conditions
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Spinal Metastases

Intervention / Treatment
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* Procedure: Arteriography and preoperative embolization
* Procedure: Arteriography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases. Informed signed consent. Exclusion Criteria: Contrast fluid allergy. Clotting disorders. Renal failure. Not suitable for arterial access. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative embolization<br>32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery. | Procedure: Arteriography and preoperative embolization<br>* Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.<br>* Other names: Embolization;|
| Active Comparator: Control group<br>32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery. | Procedure: Arteriography<br>* Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.<br>* Other names: Angiography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss |  | Measured intraoperatively and 24 hours postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood transfusion volume |  | Intraoperatively and until 48 hours postoperatively. | 
| Surgical procedure time. | Defined as the amount of time (measured in minutes) from skin incision to skin closure. | At skin closure. | 
| Vascularization grade of metastasis |  | At the angiographic procedure prior to embolization performed 0-48 hours before surgery. | 
| Success of embolization |  | Directly after the embolization performed 0-48 hours before surgery. | 
| Adverse events related to angiography or embolization |  | Within 2 postoperative days | 
| Adverse events related to surgery |  | Within 2 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic angiography, Preoperative embolization, Transcatheter arterial embolization, Embolization, Surgical blood loss, Spinal metastases, Spinal neoplasms, Vertebral metastases, metastatic spine surgery, Spinal surgery