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CompletedNCT00720954Updated Jul 23, 2008

Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

An interventional study of Ct-guided pleural needle biopsy and Thoracoscopy in Pleural Effusion and Pleural Diseases, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-07-23.

Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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.
03

In context

Pleural Effusion

324 studies on the registry are indexed under Pleural Effusion; 62 are open to participants now.

This study's enrollment of 124 is above the median of 63 across 212 interventional studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

Eskisehir Osmangazi University is the lead sponsor of 149 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Patients who went under pleural biopsy before
  2. Arrythmia
  3. Hypertensive attack during biopsy
  4. Bleeding diathesis
  5. Hypoxemia
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Enrollment
124 participants (actual)

Study arms

  • Other
    A

    CT guided pleural needle biopsy

    Procedure: Ct-guided pleural needle biopsy

  • Other
    B

    Thoracoscopy

    Procedure: Thoracoscopy

Interventions

  • ProcedureCt-guided pleural needle biopsy

    Biopsy of pleura

    Also known as: Diagnose

  • ProcedureThoracoscopy

    Biopsy of pleura

    Also known as: Diagnose

06

What researchers measure

Primary outcomes

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

    Time frame: 30 months

Secondary outcomes

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

    Time frame: 30 months

07

Study locations

1 site
  • ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES
    Eskisehir, 26220, Turkey
08

References and documents

Publications

  • 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. PubMed 20154079 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00720954
Lead sponsor
Eskisehir Osmangazi University
First posted
Jul 23, 2008
Start date
Jan 2006
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jul 23, 2008
View the source record on ClinicalTrials.gov ↗

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