A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study. One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following groups: Group A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions
Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 80
Healthy Volunteers: f
View:
• Medical thoracoscopy being performed for obtaining a pleural biopsy
Locations
Other Locations
India
Postgraduate Institute of Medical Education and Research
RECRUITING
Chandigarh
Contact Information
Primary
Sahajal Dhooria, MD, DM
sahajal@gmail.com
+919530661388
Backup
Ritesh Agarwal, MD, DM
agarwal.ritesh@outlook.in
+919478402976
Time Frame
Start Date: 2018-03-01
Completion Date: 2023-09-30
Participants
Target number of participants: 100
Treatments
Experimental: Mini-thoraoscopy
The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used for performing thoracoscopic pleural biopsies. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.
Active_comparator: Conventional rigid thoracoscopy
The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used for performing thoracoscopic pleural biopsies. It has an outer diameter of 10 mm and channel internal diameter of 5 mm.
Related Therapeutic Areas
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh