Clinical Trial: A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions

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.

Detailed Summary:
Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome: Diagnostic yield of thoracoscopic biopsy by intention to treat analysis [ Time Frame: 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


Original Primary Outcome: Diagnostic yield of thoracoscopic biopsy by intention to treat analysis [ Time Frame: 20 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


Current Secondary Outcome:

  • Yield of biopsies successfully completed [ Time Frame: 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 [ Time Frame: 3 months ]
    Number of major and minor complications encountered in the two arms
  • Scar size [ Time Frame: At the end of the procedure ]
    Scar size (in mm) in the longest axis
  • Biopsy size [ Time Frame: At the end of the procedure ]
    Biopsy size (in mm) in the longest axis


Original Secondary Outcome: Yield of biopsies successfully completed [ Time Frame: 20 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


Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: November 7, 2012
Date Started: April 2011
Date Completion:
Last Updated: January 9, 2013
Last Verified: January 2013