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Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

Primary Purpose

Pleural Effusion, Pleural Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ct-guided pleural needle biopsy
Thoracoscopy
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Effusion focused on measuring Thoracoscopy, Pleural needle biopsy, Malignant pleural diseases, Mesothelioma, Diagnosis, Pleurisy tuberculosis, Patients with pleural diseases and pleural effusion should have been included in the study.

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ages between 18-85
  2. Pleural effusion in conventional radiography
  3. At least 10x10 cm space in pleural space with effusion
  4. No bleeding diathesis
  5. Informed consent

Exclusion Criteria:

  1. Patients who went under pleural biopsy before
  2. Arrythmia
  3. Hypertensive attack during biopsy
  4. Bleeding diathesis
  5. Hypoxemia

Sites / Locations

  • ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

CT guided pleural needle biopsy

Thoracoscopy

Outcomes

Primary Outcome Measures

Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases

Secondary Outcome Measures

Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.

Full Information

First Posted
July 21, 2008
Last Updated
July 22, 2008
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT00720954
Brief Title
Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy
Official Title
Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.
Detailed Description
Pleural needle biopsy with Abrams needle, which can be performed by all chest physicians, is a simple, safe and cheap method of obtaining tissue from pleura, but its diagnostic rate is between 7 % -72 %, ~ 50 %. Problems for Abrams needle are scattered tumoral involvement on pleura, blind performance, small tissue sampling, to tend to early and dense fibrosis and usually involvement of lower pleural surface and diaphragmatic pleura. Pleural needle biopsy with Abrams' needle, which can be performed by all chest physicians, if done with image guided and if this increase the diagnosis rate, the number of second procedure which is more expensive and hard will decrease. The study aims the comparison of rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion. It has been planned that a total of 120 patients accepted to the study who have pleural effusion at plain chest roentgenogram. All patients are being randomized after underwent contrast-enhanced CT. Undiagnosed patients of biopsy group are performed thoracoscopy and undiagnosed patients of thoracoscopy group followed up. Two groups will compare by age, sex, Karnofsky performance status (KPS), diagnosis and complication rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Pleural Diseases
Keywords
Thoracoscopy, Pleural needle biopsy, Malignant pleural diseases, Mesothelioma, Diagnosis, Pleurisy tuberculosis, Patients with pleural diseases and pleural effusion should have been included in the study.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
CT guided pleural needle biopsy
Arm Title
B
Arm Type
Other
Arm Description
Thoracoscopy
Intervention Type
Procedure
Intervention Name(s)
Ct-guided pleural needle biopsy
Other Intervention Name(s)
Diagnose
Intervention Description
Biopsy of pleura
Intervention Type
Procedure
Intervention Name(s)
Thoracoscopy
Other Intervention Name(s)
Diagnose
Intervention Description
Biopsy of pleura
Primary Outcome Measure Information:
Title
Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages between 18-85 Pleural effusion in conventional radiography At least 10x10 cm space in pleural space with effusion No bleeding diathesis Informed consent Exclusion Criteria: Patients who went under pleural biopsy before Arrythmia Hypertensive attack during biopsy Bleeding diathesis Hypoxemia
Facility Information:
Facility Name
ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES
City
Eskisehir
ZIP/Postal Code
26220
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
20154079
Citation
Metintas M, Ak G, Dundar E, Yildirim H, Ozkan R, Kurt E, Erginel S, Alatas F, Metintas S. Medical thoracoscopy vs CT scan-guided Abrams pleural needle biopsy for diagnosis of patients with pleural effusions: a randomized, controlled trial. Chest. 2010 Jun;137(6):1362-8. doi: 10.1378/chest.09-0884. Epub 2010 Feb 12.
Results Reference
derived
Links:
URL
http://www.ogu.edu.tr
Description
University

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Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

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