Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

Study Overview
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Brief Summary
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The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.

Detailed Description
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The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield 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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Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

Conditions
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Pleural Effusion, Pleural Diseases

Intervention / Treatment
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* Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)


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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryobiopsy<br>Biopsies 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. The biopsy sample will by extracted by gently pulling of the probe. | Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)<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.<br>* Other names: Autoclavable cryoprobe 20416-032 (ERBE, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe | To determine, wheather cryobiopsy specimen can be obtained in each patient | 12 months | 
| Size of biopsy samples | Size of the biopsy specimens in mm2 | 12 months | 
| Quality of the sample | 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 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Number of patients with a certain degree of bleeding from biopsy site, described 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