Contained Hepatic Vascular Injuries Following Liver Trauma

Liver Injury Clinical Trial

Official title:

Contained Hepatic Vascular Injuries Following Liver Trauma: a Retrospective Monocentric Study and Review of the Literature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249646
• Other study ID #: 24Urgences01
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: For thirty years, a major shift in the management of liver trauma has been seen. Contained hepatic vascular injuries (CHVI), including pseudo aneurysms and arteriovenous fistula, are often feared due to their risk of secondary bleeding. Nonetheless, knowledge of CHVI is scarce and no guidelines on their management have been set. The investigators aimed to validate the risk factors of CHVI, identify associated morbidities, and establish a management protocol.

Study Design: A retrospective study on 318 liver trauma from a level 1 trauma center over the last 15 years, comparing the presence or not of CHVI. Univarious and multivarious analyses were performed. A comparison of the management of CHVI was also performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: March 31, 2023
• Est. primary completion date: October 31, 2022
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• presence of liver trauma

• age above 15 years old

• a full contrast abdominal CT

Exclusion Criteria: none

Related Conditions & MeSH terms

• Hepatic Injury
• Liver Injury
• Pseudoaneurysm
• Vascular System Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a % of CHVI on the initial or the follow-up Chest-Thorax scans.	A junior and a senior radiologist reviewed all initial and follow-up CT scans, blinded from the diagnostic.; Contained hepatic vascular injuries (CHVI) was defined as Hepatic Pseudoaneurysm (HPA) and/or arterio-venous fistula (AVF), under the American Association for Surgery of Trauma (AAST) organ injury scale (2018 revision) for liver trauma definition: a contained focal collection of vascular contrast which decreases in attenuation on delayed phase images on contrast-enhanced CT	6 months
Secondary	Investigate the management of CHVI following liver trauma.	size in millimeters of pseudoaneurym conducting to angio-embolization	6 months