Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization

Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization : a "Real-life" Retrospective Monocentric Study

NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.

Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.

The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting.

Study Overview

• Status: Completed
• Conditions: Haemostasis Embolisation
• Intervention / Treatment: Other: Clinical data; Other: Imaging data; Other: Biological data

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.

Description

Inclusion Criteria:

• All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.

Exclusion Criteria:

• Patients lost for follow-up, patients without preoperative CT.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Included patients; All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.	Other: Clinical data; Collecting data from the medical record.; Other: Imaging data; Collecting data from the medical record.; Other: Biological data; Collecting data from the medical record.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of technical success	Analysis of angiographic results.	Month : 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of clinical success	Disappearance of signs and symptoms of bleeding during the 30 days of follow-up after WT	Month : 1
Assessment of clinical success	No endoscopic treatment	Month : 1
Assessment of clinical success	No surgical intervention	Month : 1
Assessment of clinical success	No repeat WT	Month : 1
Assessment of clinical success	Absence of death due to massive blood loss	Month : 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Rémi GRANGE, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Emergency; Hemostatic agent; NBCA bleeding; Trans-arterial embolisation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: IRBN042024/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No