Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

July 22, 2008 updated by: Eskisehir Osmangazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Eskisehir, Turkey, 26220
        • ESOGU Medical Faculty Department of Chest Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
CT guided pleural needle biopsy
Procedure: Ct-guided pleural needle biopsy
Biopsy of pleura
Other Names:
  • Diagnose
Other: B
Thoracoscopy
Procedure: Thoracoscopy
Biopsy of pleura
Other Names:
  • Diagnose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases
Time Frame: 30 months
30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 22, 2008

First Posted (Estimate)

July 23, 2008

Study Record Updates

Last Update Posted (Estimate)

July 23, 2008

Last Update Submitted That Met QC Criteria

July 22, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007.11.008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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