Contained Hepatic Vascular Injuries Following Liver Trauma

January 31, 2024 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06000
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Liver trauma was identified on post-injury imaging evaluation or operative exploration. Admission following the trauma could either be directly from the trauma location or be a transfer from another regional hospital. Upon admission, if the patient was stable or stabilized following intensive care management, a contrast full-body CT scan was performed. Non-operative management was the primary treatment when possible. If the patient was unstable, primary surgical management was required. Surgical management could include sole exploration, hemostatic techniques, hepatic packing, drainage, or hepatectomy. If the investigators performed a damage control laparotomy with perihepatic packing, a second surgery was performed for definitive treatment after 24-48 h. In such cases, a contrast full-body CT scan was performed after the surgery. If a CT scan was not performed in the first 24 hours, the patient was not included in this study.

Description

Inclusion Criteria:

  • presence of liver trauma
  • age above 15 years old
  • a full contrast abdominal CT

Exclusion Criteria: none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of a % of CHVI on the initial or the follow-up Chest-Thorax scans.
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the management of CHVI following liver trauma.
Time Frame: 6 months
size in millimeters of pseudoaneurym conducting to angio-embolization
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 24Urgences01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Injury

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