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

• Sponsor: Eskisehir Osmangazi University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03153501
• Collaborator: (none)
• Enrollment: 164
• Locations: 2
• Arm: 1
• Actual Duration (Months): 74.7
• Patients Per Site: 82
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diagnosis of Pleural Diseases; Medical Thoracoscopy	Diagnostic Test: CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy	N/A

Detailed Description

The primary end point of this study was the determination of the sensitivity and the complication rates of the invasive methods, Abrams needle pleural biopsy, tru-cut needle pleural biopsy, medical thoracoscopy with respect to the diagnosis of pleural disease.

Study Design

• Study Type: Interventional
• Actual Enrollment: 164 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Image guided biopsies Thoracoscopy
• Primary Purpose: Diagnostic
• Official Title: How Should be Invasive Diagnostic Algorithm in Pleural Diseases
• Actual Study Start Date: Feb 8, 2011
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Apr 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Diagnostic arm 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

Outcome Measures

Primary Outcome Measures

1. 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. [5 years]

   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.

2. 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. [5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with pleural diseases

Exclusion Criteria:

• Patients with other lung diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ESOGU Medical Faculty Department of Chest Diseases	Eskisehir	Meselik - Eskisehir	Turkey	26040
2	Eskisehir Osmangazi University Medical Faculty	Eskişehir		Turkey	26040

Sponsors and Collaborators

• Eskisehir Osmangazi University

Investigators

• Principal Investigator: Muzaffer Metintas, MD, ESOGU Medical Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Muzaffer Metintas, Medical Faculty, MD, Eskisehir Osmangazi University
• ClinicalTrials.gov Identifier: NCT03153501
• Other Study ID Numbers: PR-11-01-31-21
• First Posted: May 15, 2017
• Last Update Posted: May 15, 2017
• Last Verified: May 1, 2017

• 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
• Additional relevant MeSH terms: Pleural Diseases; Disease

Study Results

No Results Posted as of May 15, 2017