Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
NCT ID: NCT03449602
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-03-01
2023-09-30
Brief Summary
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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
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Detailed Description
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This is a prospective study that will be conducted at the Thoracic Endoscopy Suite of the Department of Pulmonary Medicine, PGIMER, Chandigarh.
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. The randomization sequence will be generated using a computer (in blocks of 10), and the allocation will be placed in opaque sealed envelopes. The patients will be randomized to the following groups:
Group A (mini-thoracoscopy): The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.
Group B (Conventional rigid thoracoscopy): The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used that has an outer diameter of 10 mm and channel internal diameter of 5 mm.
Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
Mini-thoracoscopy
Thoracoscopic pleural biopsy with the mini-thoracoscope
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.
Conventional rigid thoraoscopy
Thoracoscopic pleural biopsy with the conventional rigid thoraoscope
Interventions
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Mini-thoracoscopy
Thoracoscopic pleural biopsy with the mini-thoracoscope
Conventional rigid thoraoscopy
Thoracoscopic pleural biopsy with the conventional rigid thoraoscope
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
80 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Sahajal Dhooria
Assistant Professor
Locations
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Postgraduate Institute of Medical Education and Research
Chandigarh, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NK/3695/Res
Identifier Type: -
Identifier Source: org_study_id
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