Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases

NCT03153501 | Completed

• 1 other identifier: PR-11-01-31-21
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief Summary

Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus exists regarding which biopsy methods are appropriate for specific procedures. In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.

Conditions

Diagnosis of Pleural Diseases; Medical Thoracoscopy

Outcome Measures

Primary Outcomes (2)

• Diagnostic efficiencies of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: The sensitivity, specificity, negative predictive value and positive predictive value.

  The sensitivity, specificity, negative predictive value and positive predictive value of computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.

  5 years

• Safety of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: Rate of side effects.

  Rate of side effects comparing to each other for computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.

  5 years

Study Arms (1)

Diagnostic arm

OTHER

Patients with pleural diseases; malignant pleural diseases, tuberculous pleurisy, and other exudate required CT-guided Abrams needle biopsy, US-guided cutting needle biopsy, and medical thoracoscopy.

Diagnostic Test: CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy

Interventions

CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy DIAGNOSTIC_TEST

Diagnostic arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pleural diseases

You may not qualify if:

• Patients with other lung diseases

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (2)

ESOGU Medical Faculty Department of Chest Diseases

Eskişehir, Meselik - Eskisehir, 26040, Turkey (Türkiye)

Location

Eskisehir Osmangazi University Medical Faculty

Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (1)

• Kim SJ, Choi SM, Lee J, Lee CH, Lee SM, Yim JJ, Yoo CG, Kim YW, Han SK, Park YS. Medical Thoracoscopy in Pleural Disease: Experience from a One-Center Study. Tuberc Respir Dis (Seoul). 2017 Apr;80(2):194-200. doi: 10.4046/trd.2017.80.2.194. Epub 2017 Mar 31.

  PMID: 28416960 BACKGROUND

Study Officials

• Muzaffer Metintas, MD

  ESOGU Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Image guided biopsies Thoracoscopy
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Faculty, MD

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 15, 2017
• Study Start: February 8, 2011
• Primary Completion: February 1, 2017
• Study Completion: April 30, 2017
• Last Updated: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)