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Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00720954
Enrollment
124
Registered
2008-07-23
Start date
2006-01-31
Completion date
2008-06-30
Last updated
2008-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

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.

Interventions

PROCEDURECt-guided pleural needle biopsy

Biopsy of pleura

PROCEDUREThoracoscopy

Biopsy of pleura

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

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

Design outcomes

Primary

MeasureTime frame
Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases30 months

Secondary

MeasureTime frame
Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.30 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026