A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.

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Detailed Description

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Conditions

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Pleurisy With Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rigid thoracoscopy

Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.

Group Type ACTIVE_COMPARATOR

Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)

Intervention Type DEVICE

Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany

Semirigid thoracoscopy

The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.

Group Type ACTIVE_COMPARATOR

Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)

Intervention Type DEVICE

Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan

Interventions

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Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)

Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany

Intervention Type DEVICE

Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)

Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination

Exclusion Criteria

* Significant hypoxemia on room air
* Hemodynamic instability
* Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina)
* Refractory cough
* Lack of pleural space due to adhesions
* Uncorrected coagulopathy

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No