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

Not Applicable

Completed

• Conditions: Pleura; Exudate
• Interventions: Device: Thoracoscopy forceps

• Registration Number: NCT04761003
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Status Verified: 2021-03
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (Cryobiopsy group):	Thoracoscopy forceps	patients where patients will be subjected to thoracoscopic cryobiopsy.
Group II (Forceps group)	Thoracoscopy forceps	patients where patients will be subjected to thoracoscopic forceps biopsy.

Primary Outcome Measures

Name	Time	Method
efficacy which determined by the diagnostic yield	baseline	comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.
efficacy which determined by the size of biopsy	baseline	comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.
The incidence of complications	baseline	comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt