Systemic Air Embolism After CT-guided Lung Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

559 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Systemic air embolism is traditionally considered as an extremely rare complication of percutaneous lung biopsy. Current literature includes mainly case reports or small case series of SAE. Majority of cases resulted in cardiac and/or neurological symptoms, often causing death. In most reported cases, the diagnosis of systemic air embolism referred to clinical manifestations without radiological diagnosis at the time of the procedure. Hence, its incidence might be underestimated in case of asymptomatic patients. Immediate recognition of air embolism during the procedure has been reported as the main factor to minimize severe complications since specific management of patient can be initiated earlier.

The purpose of this study is to retrospectively assess the incidence of systemic air embolism depicted at the time of the procedure on a whole thoracic CT, systematically performed after transthoracic lung biopsy in a large cohort of consecutive patients. Secondary objectives are to determine possible influencing factors and to evaluate clinical outcomes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this retrospective cohort study, all consecutive lung biopsies performed between April 2014 to May 2016 at our department of cardiothoracic interventional radiology were included using the local thoracic biopsy database. Biopsies were scheduled after the weekly multidisciplinary lung cancer meeting approval. Pleural, parietal and mediastinal lesions were excluded due to the absence of intra-parenchymal pathway. Radiofrequency ablation and peripheral nodule marking procedure were also excluded.

A complete retrospective imaging review of the procedures was performed on a PACS workstation by an experienced chest radiologist. Clinical data was also collected from the electronic medical record system.

Variables analyzed were age, sex, spirometry data, emphysema on CT, therapeutics previously done, target lesion characteristics (location, depth, and nodule size and feature), patient position, length of intrapulmonary biopsy path, number of pleural needle passes, biopsy length and number of biopsy passes. Procedural air embolism and other associated complications (hemoptysis and pneumothorax) and their management and consequences (length of hospitalization and additional action) were recorded.

Patient's characteristics with and without air embolism were compared using Student or Wilcoxon rank test for continuous variables and Chi-square or Fisher test for categorical ones. To determine the relative importance of air embolism occurrence influencing factors, multivariate logistic regression analysis was performed on variables according to significance level or clinical coherence. A backward selection was used; the α-to-enter and the α-to-exit were set, respectively, at 0.20 and 0.10. Statistical bilateral significance threshold was set at 5%. Statistical analyses were performed using SAS version 9.1 (SAS Institute, Cary, North Carolina).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Who Underwent Percutaneous Lung Biopsy Under CT Guidance Patients Who Presented Systemic Air Embolism After Percutaneous Lung Biopsy Under CT Guidance Depicted at the Time of the Procedure on a Whole Thoracic CT

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CT Interventional radiology Lung biopsy Transthoracic biopsy Systemic air embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Percutaneous lung biopsy under CT guidance

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- percutaneous CT guided lung biopsies

Exclusion Criteria

* absence of intra-parenchymal pathway (pleural, parietal or mediastinal lesions)
* radiofrequency ablation
* peripheral nodule marking procedure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valérie Monnin-Bares

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uhmontpellier

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL17_0326

Identifier Type: -

Identifier Source: org_study_id