Preoperative Embolization in Surgical Treatment of Spinal Metastases.
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|ClinicalTrials.gov Identifier: NCT01365715|
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : February 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Spinal Metastases||Procedure: Arteriography and preoperative embolization Procedure: Arteriography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Preoperative embolization
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
Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.
Active Comparator: Control group
32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.
Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.
Other Name: Angiography
- Perioperative blood loss [ Time Frame: Measured intraoperatively and 24 hours postoperatively. ]
- Perioperative blood transfusion volume [ Time Frame: Intraoperatively and until 48 hours postoperatively. ]
- Surgical procedure time. [ Time Frame: At skin closure. ]Defined as the amount of time (measured in minutes) from skin incision to skin closure.
- Vascularization grade of metastasis [ Time Frame: At the angiographic procedure prior to embolization performed 0-48 hours before surgery. ]
- Success of embolization [ Time Frame: Directly after the embolization performed 0-48 hours before surgery. ]
- Adverse events related to angiography or embolization [ Time Frame: Within 2 postoperative days ]
- Adverse events related to surgery [ Time Frame: Within 2 postoperative days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365715
|Department of Radiology, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Study Chair:||Lars Lönn, MD, Ph.d.||Department of Radiology, Rigshospitalet. Copenhagen, Denmark.|