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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Pleurisy With Effusion

Treatments: Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan); Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)

Study type: Interventional

Funder types: Other

Identifiers

NCT01726556

1Trg-PG-2012/5054

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Rigid thoracoscopy

Active Comparator group

Description:

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

Treatment:

Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)

Semirigid thoracoscopy

Active Comparator group

Description:

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

Treatment:

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