Preoperative Embolization in Surgical Treatment of Spinal Metastases.

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Metastases
• Intervention / Treatment: Procedure: Arteriography and preoperative embolization; Procedure: Arteriography

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Radiology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Therapeutic angiography; Transcatheter arterial embolization; Embolization; Selective arterial embolization
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.	Procedure: Arteriography; Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.; Other Names: Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Chair: Lars Lönn, MD, Ph.d., Department of Radiology, Rigshospitalet. Copenhagen, Denmark.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (ESTIMATE): June 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2014
• Last Update Submitted That Met QC Criteria: February 25, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Embolization; Spinal surgery; Vertebral metastases; Spinal metastases; Surgical blood loss; Preoperative embolization; Transcatheter arterial embolization; Therapeutic angiography; Spinal neoplasms; metastatic spine surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplasms, Second Primary
• Other Study ID Numbers: H-2-2011-024 (OTHER: The Danish Committee on Biomedical Research Ethics); 2008-41-2128 (OTHER: Danish Dataprotection Agency)