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

Study Overview
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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.

Official Title
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A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions

Conditions
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Pleurisy With Effusion

Intervention / Treatment
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* Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)
* Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rigid thoracoscopy<br>Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany. | Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)<br>* Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany<br>|
| Active Comparator: Semirigid thoracoscopy<br>The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan. | Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)<br>* Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of thoracoscopic biopsy by intention to treat analysis | The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yield of biopsies successfully completed | The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms | 3 months | 
| Complications | Number of major and minor complications encountered in the two arms | 3 months | 
| Scar size | Scar size (in mm) in the longest axis | At the end of the procedure | 
| Biopsy size | Biopsy size (in mm) in the longest axis | At the end of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural effusion, Semirigid thoracoscopy, Rigid thoracoscopy