Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

Study Overview
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Brief Summary
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The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.

Detailed Description
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The investigators are going to compare diagnostic yield and size, morphological features, immunohistochemistry as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

Official Title
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Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

Conditions
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Pleural Effusion, Pleural Diseases

Intervention / Treatment
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* Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 or more years old unilateral pleural effusion of unknown origin pleural irregularities suspicious for pleural malignancy referral for thoracoscopy after less invasive means of diagnosis had failed Exclusion Criteria: uncontrolled bleeding tendency unstable cardiovascular status severe heart failure ECOG performance status 4 persistent hypoxemia after evacuation of pleural fluid pleural symphisis, fibrothorax

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryobiopsy, forceps biopsy<br>Cryoiopsies will be obtained by flexible autoclavable cryoprobe 20416-032 (Erbokryo CA, ERBE, Germany) with 2.4 mm in diameter. The tip of the probe is cooled to -890C with nitrous oxide within seconds after footswitch activation. Forceps biopsies will be obtained by flexible FB-55CD-1 Olympus forceps. | Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps<br>* The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline. Forceps biopsy will be performed on usual way.<br>* Other names: Flexible FB-55CD-1 Olympus forceps;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of forceps biopsy and cryobiopsy samples | diagnostic yield size of the biopsy specimens in mm2 interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible) assessment of biopsy-related artifacts by describing the amount of unaltered tissue in quartiles | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The degree of bleeding at the biopsy site will be assessed as 1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resusucitation. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flex-rigid pleuroscopy, cryobiopsy, pleural biopsy, pleural effusion, safety, thoracoscopy