Pleurisy With Effusion Clinical Trial
— RISEOfficial title:
A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| India | Postgraduate Institute of Medical Education and Research | Chandigarh |
| Lead Sponsor | Collaborator |
|---|---|
| Postgraduate Institute of Medical Education and Research |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Other | Operators' experience characteristics | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | Complications | Number of major and minor complications encountered in the two arms | 3 months | Yes |
| Secondary | Scar size | Scar size (in mm) in the longest axis | At the end of the procedure | No |
| Secondary | Biopsy size | Biopsy size (in mm) in the longest axis | At the end of the procedure | No |