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

Not Applicable

Completed

• Conditions: Pleurisy With Effusion
• Interventions: Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany); Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)

• Registration Number: NCT01726556
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-10
• Study First Posted: 2012-11-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-09
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rigid thoracoscopy	Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)	Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.
Semirigid thoracoscopy	Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)	The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of thoracoscopic biopsy by intention to treat analysis	3 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India