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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rigid thoracoscopy | Active Comparator | Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany. |
|
| Semirigid thoracoscopy | Active Comparator | The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany) | Device | Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Use of sedation and analgesia during the procedure | The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms | At the end of procedure |
| Operators' experience characteristics |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ritesh Agarwal, MD, DM | PGIMER, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Institute of Medical Education and Research | Chandigarh | Chandigarh | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24106326 | Derived | Dhooria S, Singh N, Aggarwal AN, Gupta D, Agarwal R. A randomized trial comparing the diagnostic yield of rigid and semirigid thoracoscopy in undiagnosed pleural effusions. Respir Care. 2014 May;59(5):756-64. doi: 10.4187/respcare.02738. Epub 2013 Oct 8. |
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| Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan) | Device | Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan |
|
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 |
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
| At the end of the procedure |
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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