Modified Thoracoscopic Pleural Cryobiopsy in Diagnosis of Exudative Pleural Effusion of Undetermined Etiology
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Alexandria University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Comparison between pleural biopsy specimens obtained by modified cryoprobe technique and conventional rigid forceps during medical thoracoscopy in diagnosis of pleural effusion regarding depth of the obtained pleural biopsies.
Study Overview
Brief Summary
Background: Rigid thoracoscopy is the gold standard tool for diagnosing exudative pleural effusion but sometimes it is difficult to obtain sufficient biopsies using the conventional forceps.
Objectives: This study evaluated the efficacy, safety and diagnostic value of a modified technique using cryoprobe to obtain pleural biopsies during thoracoscopy.
Methods: This is a single center prospective study in patients who will undergo rigid thoracoscopy using conventional rigid forceps followed by a cryoprobe from the same site after injection of subpleural mixture of adrenaline and xylocaine. Biopsies will be reviewed by an independent pathologist; any complications will be recorded, and all patients will be followed up post procedure.
Detailed Description
Brief Summary: Background: Rigid thoracoscopy is the gold standard tool for diagnosing exudative pleural effusion but sometimes it is difficult to obtain sufficient biopsies using the conventional forceps..
Objectives: This study evaluated the efficacy, safety and diagnostic value of a modified technique using cryoprobe to obtain pleural biopsies during thoracoscopy.
Methods: This is a single center prospective study in patients who will undergo rigid thoracoscopy using conventional rigid forceps followed by a cryoprobe from the same site after injection of subpleural mixture of adrenaline and xylocaine. Biopsies will be reviewed by an independent pathologist and any complications will be recorded.
Detailed Description: The present study will prospectively enroll 24 patients with undiagnosed exudate pleural effusion who are admitted to Alexandria Main University Hospital , chest department .
All patients will undergo thoracoscopy whom biopsies will be taken using the modified cryo-biopsy technique and the conventional forceps biopsy technique.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patient with undiagnosed exudative pleural effusion
Exclusion Criteria
- •Any contraindications to medical thoracoscopy like:
- •Inability to tolerate lateral decubitus position Unstable cardiovascular or hemodynamic status Presence of severe, uncorrectable hypoxemia despite oxygen therapy Bleeding diathesis Refractory cough Drug Hypersensitivity Reduced general health status with short suspected survival
- •Refusal to participate
Outcomes
Primary Outcomes
Comparison between pleural biopsy specimens obtained by modified cryoprobe technique and conventional rigid forceps during medical thoracoscopy in diagnosis of pleural effusion regarding depth of the obtained pleural biopsies.
Time Frame: 1 week
Depth of the pleural biopsies obtained by both procedures will be compared by "grading of fat cells" Grading will be as follows: if there will be no presence of fat cells, this will be marked as negative and if less than 5% of the biopsy will be marked as + and if 5-25% of the biopsy will be marked as ++ and if more than 25% it will take +++ in both limbs of the cryo and forceps techniques.
Comparison between pleural biopsy specimens obtained by modified cryoprobe technique and conventional rigid forceps during medical thoracoscopy in diagnosis of pleural effusion regarding size of the obtained pleural biopsies.
Time Frame: Immediately after ending the procedure
Size of the pleural biopsies obtained by both procedures will be compared in millimeters
Comparison between pleural biopsy specimens obtained by modified cryoprobe technique and conventional rigid forceps during medical thoracoscopy in diagnosis of pleural effusion regarding integrity of the obtained pleural biopsies.
Time Frame: 1 week
Integrity of the pleural biopsies obtained by both procedures will be compared by percentage of "crushed cells."" Grading will be as follows: if there will be no presence of crushed cells, this will be marked as negative and if less than 5% of the biopsy will be marked as + and if 5-25% of the biopsy will be marked as ++ and if more than 25% it will take +++ in both limbs of the cryo and forceps techniques.
Secondary Outcomes
- Safety of the procedure of thoracoscopic pleural biopsies(During the period of hospital stay)
Investigators
Ayman Baess
Associate Professor
Alexandria University