The Added Value of CT Scanning in Patients With an Unilateral Pleural Effusion

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. Identifier: NCT03270215
Recruitment Status : Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
Simon Reuter, Naestved Hospital

Brief Summary:
To investigate the diagnostic power of computed tomography for discriminating malignant from nonmalignant causes to pleural effusions in consecutive patients with no malignant cells found at a cytological examination and a chest x-ray not suspicious of malignancy. The investigators hypothesised that the combination improves the chance of detecting the cause of the pleural effusion.

Condition or disease Intervention/treatment
Pleural Effusion, Malignant Procedure: Computed tomography

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 232 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Added Value of CT Scanning for Discriminating Malignant From Non-malignant Causes in Patients With an Unilateral Pleural Effusion
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : January 31, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Intervention Details:
  • Procedure: Computed tomography
    The diagnostic power to discriminate malignant from nonmalignant causes of e pleural effusion

Primary Outcome Measures :
  1. Specificity [ Time Frame: 1 year ]
    TN / (TN+FP)

Secondary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 1 year ]
    (TP+TN) / (TP+TN+FP+FN)

  2. Likelihood ratio + [ Time Frame: 1 year ]
    LR+ = sensitivity / (1-specificity)

  3. Likelihood ratio - [ Time Frame: 1 year ]
    LR- = (1-sensitivity) / specificity

  4. Positive predictive value [ Time Frame: 1 year ]
    PPV =TP / (TP+ FP)

  5. Negative predictive value [ Time Frame: 1 year ]
    TN/ (TN + FN)

  6. Sensitivity [ Time Frame: 1 year ]
    TP / (TP + FN)

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with a unilateral pleural effusion of unknown origin

Inclusion Criteria:

  • Thoracocentesis
  • Chest X-ray and
  • CT-scanning are performed

Exclusion Criteria:

  • Lung cancer
  • Other thoracic malignancy

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 identifier (NCT number): NCT03270215

Naestved Hospital
Naestved, Denmark, 4700
Naestved Hospital
Næstved, Denmark, 4700
Sponsors and Collaborators
Naestved Hospital

Responsible Party: Simon Reuter, Ph.d.student, Naestved Hospital Identifier: NCT03270215     History of Changes
Other Study ID Numbers: CT-UPE
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Simon Reuter, Naestved Hospital:
Computed Tomography

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site