RecruitingNot ApplicableNCT03853434

Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.

Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization. Randomized Controlled Observer- Blinded


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

100 participants

Start Date

Mar 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by RCT. It is a minimally invasive procedure, not free from complications. The recent meta-analyzes, due to the limited number of patients included are not exhaustive about the effectiveness of embolization in the reduction of the intraoperative bleeding, especially in the context of poor / moderate metastasis vascularization. We want to evaluate the efficacy of preoperative angiographic embolization of intermediate / poor vascularized spine metastases in reducing intraoperative blood loss during excision surgery.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether performing a procedure called angiographic embolization before surgery can reduce bleeding during operations to decompress and stabilize the spine in patients with vertebral (spine) metastases — cancer that has spread to the spine. Embolization involves temporarily blocking blood supply to a tumor to reduce bleeding risk during surgery. The study focuses on tumors with moderate blood supply (grade 2 vascularization), comparing embolization against no embolization. Patients with spine metastases often need surgery to relieve spinal cord compression and stabilize the spine, but these surgeries can involve significant blood loss. This study aims to determine if pre-surgical embolization reduces that risk and improves outcomes. You may be eligible if: - You are between 18 and 75 years old - You have spine metastases with moderate vascularization (grade 2) - Your life expectancy is more than 6 months (Tokuhashi score ≤ 11) - Your surgery can be scheduled 48-72 hours after embolization You may NOT be eligible if: - You have blood clotting disorders or low platelet counts (PLT < 80,000) - You have kidney failure (creatinine ≥ 1.2) - You are allergic to contrast dye used in imaging - You are pregnant or breastfeeding - You have chronic ischemic heart disease - Emergency surgery is needed immediately - More than 72 hours have passed since embolization Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREEmbolization

Angiographic embolization


Locations(1)

Giancarlo Facchini

Bologna, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03853434


Related Trials