Pleurisy With Effusion
Conditions
Keywords
Pleural effusion, Semirigid thoracoscopy, Rigid thoracoscopy
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.
Interventions
DEVICERigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)
Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany
DEVICESemirigid thoracoscope (model LTF-160Y1, Olympus, Japan)
Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of sedation and analgesia during the procedure | At the end of procedure | The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms |
| Operators' experience characteristics | At the end of the procedure | These would include, on a numerical scale of 0 to 100, the operator's grading of the following characteristics: quality of thoracoscopic image, ease of maneuvering, ease of taking a biopsy and the operator's expectation that the biopsy will reveal a definitive histological diagnosis |
Countries
India
Outcome results
None listed