An interventional study of Cryoprobe in Pleural Effusion, sponsored by Assiut University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic
The purpose of this study is to evaluate the feasibility, size and quality of the specimens obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during medical thoracoscopy in diagnosis of pleural effusion.
Technique of pleural biopsy using cryotechnique:
335 studies on the registry are indexed under Pleural Effusion; 63 are open to participants now.
This study's enrollment of 60 is close to the median of 62 across 220 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
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- 1. Unilateral moderate or massive exudative pleural effusion patients. 2. Undiagnosed pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural biopsy using Abram's needle.
3. Age>18 years old
Exclusion Criteria:
Fibrothorax, excessive pleural adhesion.
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medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained
Device: Cryoprobe
* The probe (ERBE Elektromedizin GmbH; Tubingen, Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization. * The tip of the cryoprobe will be attached to suspicious part of parietal pleura . * The frozen tissue is going to be extracted by gently pulling of the probe. * Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture. * The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. * The biopsy sample will be released from the probe by thawing in the saline. * The semirigid pleuroscope will be reintroduced through the port and the pleura will be revisualized for bleeding.
comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.
1\_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).
Time frame: 12 months
Complication assessment
To evaluate the safety and occurrence of complication such as bleeding Number of patients with a certain degree of bleeding from biopsy site, described as: 1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resuscitation .
Time frame: 12 months
assessment pleural fluid
comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.
Time frame: 12 months
assessment of post procedure pain
comparison between meperidine and (midazolam \&NSAIDs) in controlling pain post thoracoscopy.
Time frame: 12 months
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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