RISE
A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
Sponsor study identifier
interventional
70
1 country
1
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 7, 2012
Actual (reported)November 15, 2012
Actual (reported)December 2012
Actual (reported)December 2012
Actual (reported)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
Yield of biopsies successfully completed
3 months
Complications
3 months
Scar size
At the end of the procedure
Biopsy size
At the end of the procedure
Use of sedation and analgesia during the procedure
At the end of procedure
Operators' experience characteristics
At the end of the procedure
Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.
The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.
Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany
Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012, India
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.
Ritesh Agarwal, MD, DM
PGIMER, Chandigarh
70 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2012
First Posted
November 15, 2012
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
January 10, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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