Back to results

Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Primary Purpose

Spinal Metastases

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Arteriography and preoperative embolization

Arteriography

About this trial

This is an interventional treatment trial for Spinal Metastases focused on measuring Preoperative embolization, Transcatheter arterial embolization, Therapeutic angiography, Embolization, Surgical blood loss, Spinal metastases, Spinal neoplasms, Vertebral metastases, metastatic spine surgery, Spinal surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Radiology, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preoperative embolization

Control group

Arm Description

32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.

Outcomes

Primary Outcome Measures

Perioperative blood loss

Secondary Outcome Measures

Perioperative blood transfusion volume

Surgical procedure time.

Defined as the amount of time (measured in minutes) from skin incision to skin closure.

Vascularization grade of metastasis

Success of embolization

Adverse events related to angiography or embolization

Adverse events related to surgery

Full Information

NCT ID

NCT01365715

First Posted

May 27, 2011

Last Updated

February 25, 2014

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01365715

Brief Title

Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Metastases

Keywords

Preoperative embolization, Transcatheter arterial embolization, Therapeutic angiography, Embolization, Surgical blood loss, Spinal metastases, Spinal neoplasms, Vertebral metastases, metastatic spine surgery, Spinal surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preoperative embolization

Arm Type

Experimental

Arm Description

32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.

Intervention Type

Procedure

Intervention Name(s)

Arteriography and preoperative embolization

Other Intervention Name(s)

Transcatheter arterial embolization, Selective arterial embolization, Therapeutic angiography, Embolization

Intervention Description

Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

Intervention Type

Procedure

Intervention Name(s)

Arteriography

Other Intervention Name(s)

Angiography

Intervention Description

Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.

Primary Outcome Measure Information:

Title

Perioperative blood loss

Time Frame

Measured intraoperatively and 24 hours postoperatively.

Secondary Outcome Measure Information:

Title

Perioperative blood transfusion volume

Time Frame

Intraoperatively and until 48 hours postoperatively.

Title

Surgical procedure time.

Description

Defined as the amount of time (measured in minutes) from skin incision to skin closure.

Time Frame

At skin closure.

Title

Vascularization grade of metastasis

Time Frame

At the angiographic procedure prior to embolization performed 0-48 hours before surgery.

Title

Success of embolization

Time Frame

Directly after the embolization performed 0-48 hours before surgery.

Title

Adverse events related to angiography or embolization

Time Frame

Within 2 postoperative days

Title

Adverse events related to surgery

Time Frame

Within 2 postoperative days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Lönn, MD, Ph.d.

Organizational Affiliation

Department of Radiology, Rigshospitalet. Copenhagen, Denmark.

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Radiology, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Links:

URL

http://www.rigshospitalet.dk

Description

Related Info

Learn more about this trial

Preoperative Embolization in Surgical Treatment of Spinal Metastases.

We'll reach out to this number within 24 hrs