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Systemic Air Embolism After CT-guided Lung Biopsy (SAE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03360084
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

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.


Condition or disease Intervention/treatment
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 Procedure: Percutaneous lung biopsy under CT guidance

Detailed Description:

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).

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Study Type : Observational
Actual Enrollment : 559 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Systemic Air Embolism After CT-guided Lung Biopsy: Incidence and Risk Factors Assessment
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy


Intervention Details:
  • Procedure: Percutaneous lung biopsy under CT guidance
    Percutaneous lung biopsy under CT guidance


Primary Outcome Measures :
  1. Incidence of systemic air embolism [ Time Frame: 1 day ]

    Systemic air embolism was depicted on the CT scan performed on the whole chest in the same position as for the biopsy at the end of the procedure.

    Air embolism was defined as an air collection in the left cardiac cavities or vascular systemic structure, visible in at least two consecutive slices, that was not present on the pre-therapeutic CT



Secondary Outcome Measures :
  1. Risk factors of systemic air embolism [ Time Frame: 1 day ]
    Variables were recorded using a retrospective imaging review of the biopsy procedures. Clinical data was also collected from the electronic medical record system.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360084


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Valérie Monnin-Bares University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03360084    
Other Study ID Numbers: RECHMPL17_0326
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
CT
Interventional radiology
Lung biopsy
Transthoracic biopsy
Systemic air embolism
Additional relevant MeSH terms:
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Embolism
Embolism, Air
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases