Clinical trial NCT00720954: 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
Overall status: COMPLETED
Phase: NA
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.
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases
timeFrame: 30 months
Secondary outcomes:
measure: Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.
timeFrame: 30 months
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES
Study officials:
References:
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.