Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The incidence of complications
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group II (Forceps group)
patients where patients will be subjected to thoracoscopic forceps biopsy.
Intervention: Thoracoscopy forceps (Device)
Group I (Cryobiopsy group):
patients where patients will be subjected to thoracoscopic cryobiopsy.
Intervention: Thoracoscopy forceps (Device)
Outcomes
Primary Outcomes
The incidence of complications
Time Frame: baseline
comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications
efficacy which determined by the diagnostic yield
Time Frame: baseline
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Tamer Awad
Principal Investigator
Mansoura University