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

Pleura; Exudate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761003
• Other study ID #: Thoracoscopic cryobiopsy
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleura; Exudate
• Pleural Effusion

Intervention

Device:
• Thoracoscopy forceps
take pleural biopsy

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

Bonniot JP, Homasson JP, Roden SL, Angebault ML, Renault PC. Pleural and lung cryobiopsies during thoracoscopy. Chest. 1989 Mar;95(3):492-3. — View Citation

Hetzel J, Hetzel M, Hasel C, Moeller P, Babiak A. Old meets modern: the use of traditional cryoprobes in the age of molecular biology. Respiration. 2008;76(2):193-7. doi: 10.1159/000135934. Epub 2008 Jun 26. — View Citation

Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. — View Citation

Noppen M. The utility of thoracoscopy in the diagnosis and management of pleural disease. Semin Respir Crit Care Med. 2010 Dec;31(6):751-9. doi: 10.1055/s-0030-1269835. Epub 2011 Jan 6. Review. — View Citation

Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20. Review. — View Citation

Porcel JM. Pleural fluid biomarkers: beyond the Light criteria. Clin Chest Med. 2013 Mar;34(1):27-37. doi: 10.1016/j.ccm.2012.11.002. Epub 2013 Jan 17. — View Citation

Tousheed SZ, Manjunath PH, Chandrasekar S, Murali Mohan BV, Kumar H, Hibare KR, Ramanjaneya R. Cryobiopsy of the Pleura: An Improved Diagnostic Tool. J Bronchology Interv Pulmonol. 2018 Jan;25(1):37-41. doi: 10.1097/LBR.0000000000000444. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy which determined by the diagnostic yield	comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.	baseline
Primary	efficacy which determined by the size of biopsy	comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.	baseline
Primary	The incidence of complications	comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications	baseline