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

M

Mansoura University

Status

Completed

Conditions

Pleura; Exudate

Treatments

Device: Thoracoscopy forceps

Study type

Interventional

Funder types

Other

Identifiers

NCT04761003
Thoracoscopic cryobiopsy

Details and patient eligibility

About

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

Full 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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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