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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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-01-31
2018-07-31
Brief Summary
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Detailed Description
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Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B: The above two procedures will be performed in the reverse order The biopsies will be performed from different areas of the involved pleura with the two techniques. Thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Cryobiopsy
Pleural biopsy with a flexible cryoprobe
Cryoprobe pleural biopsy first
Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).
Forceps biopsy
Pleural biopsy with a flexible forceps
Flexible forceps biopsy first
Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)
Interventions
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Cryoprobe pleural biopsy first
Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).
Flexible forceps biopsy first
Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)
Eligibility Criteria
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Inclusion Criteria
* Semirigid thoracoscopy being performed for diagnosis of the pleural effusion
Exclusion Criteria
* SpO2 \<88% on room air
* Hemodynamic instability
* Myocardial infarction or unstable angina in the last 6 wk
* Lack of pleural space due to adhesions
* Uncorrected coagulopathy
* Failure to provide informed consent
12 Years
79 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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PGIMER
Chandigarh, , India
Countries
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Other Identifiers
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NK/1815/Res/2439
Identifier Type: -
Identifier Source: org_study_id
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