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Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

This study has been completed.
Sponsor:
Information provided by:
Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT00720954
First received: July 21, 2008
Last updated: July 22, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention
Pleural Effusion
Pleural Diseases
 Procedure: Ct-guided pleural needle biopsy
Procedure: Thoracoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Diagnostic
Official Title: Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eskisehir Osmangazi University:

Primary Outcome Measures:
  • Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases [ Time Frame: 30 months ]

Secondary Outcome Measures:
  • Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings. [ Time Frame: 30 months ]

Enrollment: 124
Study Start Date: January 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
CT guided pleural needle biopsy
 Procedure: Ct-guided pleural needle biopsy
Biopsy of pleura
Other Name: Diagnose
B
Thoracoscopy
 Procedure: Thoracoscopy
Biopsy of pleura
Other Name: Diagnose

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720954

Locations
Turkey
ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES
Eskisehir, Turkey, 26220
Sponsors and Collaborators
Eskisehir Osmangazi University
  More Information

Additional Information:
University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Muzaffer Metintas
ClinicalTrials.gov Identifier: NCT00720954     History of Changes
Other Study ID Numbers: 2007.11.008
Study First Received: July 21, 2008
Last Updated: July 22, 2008
Health Authority: Turkey: Ministry of Health

Keywords provided by Eskisehir Osmangazi University:
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.

Additional relevant MeSH terms:
Pleural Diseases
Pleural Effusion
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013