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

December 15, 2020 updated by: Simon Reuter, Naestved Hospital

The Added Value of CT Scanning for Discriminating Malignant From Non-malignant Causes in Patients With an Unilateral Pleural Effusion

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objectives

  1. Is CT-scanning better than chest x-ray plus a thoracocentesis for discriminating malignant from benign pleural effusions?
  2. What is the added value of a CT-scanning to chest x-ray plus thoracocentesis for discriminating malignant from benign pleural effusions?

The above measured as, true positive, true negative, false positive, false negative, sensitivity, specificity, likelihood ratio+, likelihood ratio -, positive predictive value, negative predictive value and diagnostic accuracy.

Study design A retrospective diagnostic study including consecutive patients with a unilateral pleural effusion. Thoracocentesis, chest x-ray and CT findings are categorised as either normal (i.e. not suggestive of any aetiology of the unilateral pleural effusion), suggestive of other lung pathology or suggestive of malignancy (i.e. representing a possible aetiology of the unilateral pleural effusion). The final diagnosis is extracted from the patients' electronic medical records. When no diagnosis is found, two investigators agree on a consensus diagnosis based on all investigation results. If no reasonable diagnosis can be established based on the findings, the patient case is categorised as having no final diagnosis.

The investigators follow the STARD guideline for reporting diagnostic accuracy studies.

Patients The investigators will include consecutive patients presenting with a unilateral pleural effusion between 01 January 2013 and 31 December 2016. The patients will be identified searching the hospitals administrative patient system for the procedure code thoracocentesis (KTGA30).

Departments of Respiratory Medicine at Zealand University Hospital, Roskilde and Naestved Hospital, Region Zealand, Denmark, participate in this study. Both hospitals are a large tertiary hospital with specialised functions. Patients older than 16 years are included, irrespective of smoking history and comorbidities, if both thoracocentesis, chest x-ray and a CT-scanning are performed. Exclusion criteria are previously diagnosed lung cancer, thoracic malignancy or incomplete data.

Data Relevant data on demographics, descriptive data, symptoms, medical history and diagnostic workup will be extracted from electronic medical records, and registered in the individual patient's case report file (CRF). The CRF is stored using Excel on an encrypted USB-key, the USB-key will be stored behind double lock (room plus cupboard). Background-variables will be utilised to describe the study population and for explorative research. Only study coordinators will have access to data. Computers, as well as a back-up, will be stored and kept in a locked cupboard in a locked room. Only study coordinators possess relevant keys.

Statistics Data will be presented as frequencies and/or mean ± standard deviation (SD). Test characteristics will be compared using McNemar's test with a Bonferroni correction. An alpha level of 0.05 is considered significant. Test characteristics for thoracocentesis, chest x-ray and CT-scanning and the combination of the three will be calculated. Test characteristics are true positive, true negative, false positive, false negative, sensitivity, specificity, likelihood ratio+, likelihood ratio-, positive predictive value, negative predictive value and diagnostic accuracy.

The combined sensitivity of two parallel tests will be calculated using the formula:

The sensitivity of test A + sensitivity of test B - (sensitivity of test A x sensitivity of test B)

The combined specificity for two parallel tests will be calculated using the formula:

The specificity of test A x specificity of test B

The combined sensitivity of three parallel tests will be calculated using the formula:

The sensitivity of test A + sensitivity of test B + sensitivity of test C - (sensitivity of test A x sensitivity of test B x sensitivity of test C)

The combined specificity for three parallel tests will be calculated using the formula:

The specificity of test A x specificity of test B x sensitivity of test C For data analysis, we use STATA (StataCorp LLC, Version 15.0, College Station, Texas, USA).

Ethics The study is retrospective and observational and thus will not affect the included patients. Before any study-related activity, the protocol and study must be approved by the Danish Data Protection Agency and the local Committee on Biomedical Research Ethics. All results will be stored and analysed by computer, and the investigators secure the patients' anonymity according to the national laws. The data are anonymized and stored after completion of the study and data containing personal identification numbers will be kept behind double-lock at the department.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

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

  • Denmark
      • Naestved, Denmark, 4700
        • Naestved Hospital
      • Næstved, Denmark, 4700
        • Naestved Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with a unilateral pleural effusion of unknown origin

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Lung cancer
  • Other thoracic malignancy

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: 1 year
TN / (TN+FP)
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: 1 year
(TP+TN) / (TP+TN+FP+FN)
1 year
Likelihood ratio +
Time Frame: 1 year
LR+ = sensitivity / (1-specificity)
1 year
Likelihood ratio -
Time Frame: 1 year
LR- = (1-sensitivity) / specificity
1 year
Positive predictive value
Time Frame: 1 year
PPV =TP / (TP+ FP)
1 year
Negative predictive value
Time Frame: 1 year
TN/ (TN + FN)
1 year
Sensitivity
Time Frame: 1 year
TP / (TP + FN)
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Naestved Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-UPE

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.

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