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Completed

NCT Number: NCT00720954

Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES

Eskişehir, 26220, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ct-guided pleural needle biopsy

Procedure

Biopsy of pleura

Other names: Diagnose

Thoracoscopy

Procedure

Biopsy of pleura

Other names: Diagnose

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

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 23, 2008
Registry last updated
Jul 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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