NCT05428891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

4.8 years

First QC Date

June 15, 2022

Last Update Submit

September 7, 2023

Conditions

Diagnosis of Pleural Diseases

Keywords

PleuraThoracoscopyPleural needle biopsyDiagnosis

Outcome Measures

Primary Outcomes (1)

  • The efficacy of pleural biopsy methods for the diagnosis of pleural diseases.

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

    60 months

Study Arms (2)

Only pleural effusion

OTHER

The patients with only pleural effusion on their CT scans.

Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.

Pleural effusion associated with pleural thickening or any other lesion like mass or nodules.

OTHER

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 (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.

Interventions

Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.PROCEDURE

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

Also known as: A diagnostic algorithm for pleural diseases.
Only pleural effusionPleural effusion associated with pleural thickening or any other lesion like mass or nodules.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pleural effusion Malignant pleural diseases Pleurisy tuberculosis Benign pleural diseases

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases

Eskişehir, Tepebaşı, 260140, Turkey (Türkiye)

Location

Related Publications (1)

  • Metintas M, Ak G, Yildirim H, Dundar E, Aydin N, Erginel S, Alatas F, Yilmaz S, Metintas S. Image-Assisted Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial. Chest. 2024 Aug;166(2):405-412. doi: 10.1016/j.chest.2024.03.038. Epub 2024 Mar 28.

    PMID: 38554817DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Muzaffer Metintas, Prof.

    Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants do not know which method will apply.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 23, 2022

Study Start

April 30, 2017

Primary Completion

February 27, 2022

Study Completion

May 1, 2022

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)