Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06066398
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-09-06
Brief Title:
Thoracoscopic Pleural Lavage and Brushing in Undiagnosed Pleural Effusion
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Evaluation of Thoracoscopic Pleural Lavage and Pleural Brushing as Unconventional Methods for Diagnosis of Pleural Effusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To evaluate the diagnostic yield and safety of thoracoscopic pleural lavage and pleural brushing in cases of undiagnosed exudative pleural effusion
Detailed Description:
The diagnosis of etiology of pleural effusions remains a challenging issue even after diagnostic thoracocentesis and closed pleural biopsy in significant number of cases In order to get a pleural biopsy or the diagnosis of undiagnosed pleural effusion several techniques were used such as percutaneous needle pleural biopsy CT guided pleural biopsy medical thoracoscopy video-assisted thoracoscopy and open thoracotomy
Medical thoracoscopy plays a huge role with a great diagnostic yield in the diagnosis of exudative pleural effusion Pleural biopsy is considered to be a gold standard investigation of choice in patients with undiagnosed exudative pleural effusions It can be used to describe the diagnostic and therapeutic exploration of the pleural space mostly under local anesthesia with or without conscious sedation unlike video-assisted thoracoscopic surgery VATS which is conducted under general anesthesia with single lung ventilation
Pleural biopsy with forceps is the usual mode of obtaining thoracoscopic specimens from suspected pleural lesions However this may be associated with complications like bleeding that hinders further biopsy additionally the decision to take biopsy could be difficult especially when the targeted lesions are on the visceral pleura or near the vessels
On the other hand pleural brush could be used to safely obtain pleural specimens through medical thoracoscopy from suspected areas either in the parietal visceral pleura or near the vascular structure
The use of pleural lavage performed by injecting normal saline to pleural space and aspirated at the time of thoracoscopy would provide a higher diagnostic yield than the cytologic analysis of the fluid obtained at thoracentesis and could provide additional diagnostic information to thoracoscopic biopsy This finding could be explained by one of the following
1 The cells in the lavage are fresher and have not undergone degeneration as have many cells in the pleural fluid
2 The lavage procedure could dislodge cells that would not have been detached otherwise Tumor cells seeded in the subserous layer are exfoliated into the pleural cavity and lavage could lead to the recovery of malignant cells
3 Biopsies of the parietal and visceral pleura could have exposed the tumor and allowed malignant cells to be shed into the lavage fluid
Medical thoracoscopy plays a huge role with a great diagnostic yield in the diagnosis of exudative pleural effusion Pleural biopsy is considered to be a gold standard investigation of choice in patients with undiagnosed exudative pleural effusions It can be used to describe the diagnostic and therapeutic exploration of the pleural space mostly under local anesthesia with or without conscious sedation unlike video-assisted thoracoscopic surgery VATS which is conducted under general anesthesia with single lung ventilation
Pleural biopsy with forceps is the usual mode of obtaining thoracoscopic specimens from suspected pleural lesions However this may be associated with complications like bleeding that hinders further biopsy additionally the decision to take biopsy could be difficult especially when the targeted lesions are on the visceral pleura or near the vessels
On the other hand pleural brush could be used to safely obtain pleural specimens through medical thoracoscopy from suspected areas either in the parietal visceral pleura or near the vascular structure
The use of pleural lavage performed by injecting normal saline to pleural space and aspirated at the time of thoracoscopy would provide a higher diagnostic yield than the cytologic analysis of the fluid obtained at thoracentesis and could provide additional diagnostic information to thoracoscopic biopsy This finding could be explained by one of the following
1 The cells in the lavage are fresher and have not undergone degeneration as have many cells in the pleural fluid
2 The lavage procedure could dislodge cells that would not have been detached otherwise Tumor cells seeded in the subserous layer are exfoliated into the pleural cavity and lavage could lead to the recovery of malignant cells
3 Biopsies of the parietal and visceral pleura could have exposed the tumor and allowed malignant cells to be shed into the lavage fluid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None