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Completed

NCT Number: NCT04761003

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

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

Completed

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Key information

Conditions

Pleura; Exudate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracoscopy forceps

Device

take pleural biopsy

Other names: Thoracoscopic cryobiopsy

Primary outcomes

  1. efficacy which determined by the diagnostic yield

    Time frame: baseline

    comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.

  2. efficacy which determined by the size of biopsy

    Time frame: baseline

    comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.

  3. The incidence of complications

    Time frame: baseline

    comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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