Invasive Methods in the Diagnosis of Pleural Diseases: Which, When; An Algorithm Suggestion

Sponsor
Eskisehir Osmangazi University (Other)
Overall Status
Completed
CT.gov ID
NCT05428891
Collaborator
(none)
228
1
2
60
3.8

Study Details

Study Description

Brief Summary

Pleural diseases can occur due to numerous pathological conditions. The increasing prevalence of etiologic causes and aging population worldwide will make pleural diseases a growing problem in the coming years. As a result of this increase, the need for diagnostic investigations is also increasing. In recent years, the use of image-guided needle biopsies under ultrasound (US) or computed tomography (CT) and the increasing use of medical thoracoscopy (MT) have significantly increased the accuracy of diagnosis of pleural disease. There is not yet a generally accepted algorithm for invasive diagnosis of pleural disease, widely used in clinics, that determines which method should be used in which patient. It would be necessary and valuable to develop an algorithm based on imaging findings in particular to improve the diagnostic accuracy, safety, and cost of the procedure. The investigators aimed to test the algorithm in an interventional study to increase the level of evidence in this study.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Abrams' needle pleural biopsy versus medical thoracoscopy in the diagnosis of pleural diseases.
N/A

Detailed Description

No consensus exists regarding which biopsy methods are appropriate for specific procedures. In this randomized prospective study, the investigators aimed to compare computed tomography scan-guided pleural biopsy using an Abrams' needle (CT-ANPB) with medical thoracoscopy (MT) according to the CT findings of the patients concerning both diagnostic yield and safety.

Between May 2017 and March 2022, 228 patients with exudative pleural effusion who the cytological analysis could not diagnose were included. All patients were separated into two groups regarding the CT findings: Only pleural effusion or pleural effusion with pleural thickening/lesion. In each group, the patients were randomized to either underwent CT-ANPB or underwent MT. The two groups were compared in terms of diagnostic sensitivity, accuracy, and complications.

Study Design

Study Type:
Interventional
Actual Enrollment :
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized prospectiveRandomized prospective
Masking:
Single (Participant)
Masking Description:
Participants do not know which method will apply.
Primary Purpose:
Diagnostic
Official Title:
Invasive Methods in the Diagnosis of Pleural Diseases
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Only pleural effusion

The patients with only pleural effusion on their CT scans.

Procedure: Abrams' needle pleural biopsy versus medical thoracoscopy in the diagnosis of pleural diseases.
We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
Other Names:
  • A diagnostic algorithm for pleural diseases.
  • Other: Pleural effusion associated with pleural thickening or any other lesion like mass or nodules.

    The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans.

    Procedure: Abrams' needle pleural biopsy versus medical thoracoscopy in the diagnosis of pleural diseases.
    We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
    Other Names:
  • A diagnostic algorithm for pleural diseases.
  • Outcome Measures

    Primary Outcome Measures

    1. The efficacy of pleural biopsy methods for the diagnosis of pleural diseases. [60 months]

      To compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 86 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Pleural effusion Malignant pleural diseases Pleurisy tuberculosis Benign pleural diseases

    Exclusion Criteria:

    Age less than 18 years, Parapneumonic effusion, Presence of other systemic diseases that could interfere radiological evaluation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases Eskisehir Tepebaşı Turkey 260140

    Sponsors and Collaborators

    • Eskisehir Osmangazi University

    Investigators

    • Principal Investigator: Muzaffer Metintas, Prof., Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Muzaffer Metintas, Professor, Eskisehir Osmangazi University
    ClinicalTrials.gov Identifier:
    NCT05428891
    Other Study ID Numbers:
    • 80558721/162
    First Posted:
    Jun 23, 2022
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Muzaffer Metintas, Professor, Eskisehir Osmangazi University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2022