Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

Study Overview
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Brief Summary
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This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

Detailed Description
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Consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups: 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.

Official Title
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A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study

Conditions
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Pleural Effusion, Pleurisy, Tuberculosis, Metastatic Malignancy

Intervention / Treatment
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* Device: Cryoprobe pleural biopsy first
* Device: Flexible forceps biopsy first


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥12 years Semirigid thoracoscopy being performed for diagnosis of the pleural effusion Exclusion Criteria: Age ≥80 years 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryobiopsy<br>Pleural biopsy with a flexible cryoprobe | Device: Cryoprobe pleural biopsy first<br>* 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).<br>|
| Active Comparator: Forceps biopsy<br>Pleural biopsy with a flexible forceps | Device: Flexible forceps biopsy first<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy | The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy size | Size of biopsy specimens obtained with the two techniques | One day | 
| Duration of procedure | Time taken for the procedure with the two techniques | One day | 
| Ease of biopsy VAS | Ease of taking biopsy with the two techniques assessed using a visual analog scale | One day | 
| Artifacts | Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe | One day | 
| Tissue depth | Depth of the tissue obtained on histopathology | One day | 
| Bleeding | Number of participants with bleeding seen while taking biopsy categorised into no bleeding, minimal self limited ooze, bleeding requiring prolonged suctioning , major hemorrhage requiring blood transfusion, causing hemodynamic instability or ICU admission | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracoscopy, pleuroscopy, semirigid thoracoscopy, flexible cryoprobe, cryobiopsy, pleural biopsy