Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion

Study Overview
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Brief Summary
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To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion

Detailed Description
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Pleural effusions are either transudate or exudate according to the biochemical analysis of aspirated pleural fluid. Thoracentesis or blind pleural biopsy may not provide a definitive diagnosis. Cryobiopsy has more successful diagnostic results than forceps biopsies with complications (only hemorrhage) during procedures. Cryobiopsy can obtain more diagnostic biopsies due to the size of the biopsies and best property in expressions of an artifact-free sample area

Official Title
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Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion

Conditions
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Pleura; Exudate

Intervention / Treatment
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* Device: Thoracoscopy forceps


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study Exclusion Criteria: patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A full medical history was obtained. Medical history, clinical examination and local chest examination for signs of pleural effusion, Radiological data include chest X-ray, chest computed tomography (CT), and chest ultrasound (US) for localization of a better entry site. Thoracoscopy procedure the procedure was performed in the lateral decubitus position with the affected side upward under conscious sedation. Local anesthesia consisting of 2% lignocaine was administered to the skin, subcutaneous tissue, muscle, and parietal pleura. The appearance of the parietal and visceral pleural was assessed and recorded. Pleural biopsies were obtained using rigid forceps and cryoprobe during rigid medical thoracoscopy Complications during thoracoscopy were recorded as bleeding and surgical emphysema. Samples were directly fixed in 10% formalin solution Biopsies obtained were examined pathologically with stress on size and quality of the sample.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (Cryobiopsy group):<br>patients where patients will be subjected to thoracoscopic cryobiopsy. | Device: Thoracoscopy forceps<br>* take pleural biopsy<br>* Other names: Thoracoscopic cryobiopsy;|
| Active Comparator: Group II (Forceps group)<br>patients where patients will be subjected to thoracoscopic forceps biopsy. | Device: Thoracoscopy forceps<br>* take pleural biopsy<br>* Other names: Thoracoscopic cryobiopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy which determined by the diagnostic yield | comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield. | baseline | 
| efficacy which determined by the size of biopsy | comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy. | baseline | 
| The incidence of complications | comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications | baseline |