Thoracoscopic Pleural Lavage and Brushing in Undiagnosed Pleural Effusion

Disorder of Pleura and Pleural Cavity Clinical Trial

Official title:

Evaluation of Thoracoscopic Pleural Lavage and Pleural Brushing as Unconventional Methods for Diagnosis of Pleural Effusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06066398
• Other study ID #: Thoraco pleural lavage & brush
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: Amira Emad El-din
• Phone: 01019937498
• Email: tota_eg1993[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. To evaluate the diagnostic yield and safety of thoracoscopic pleural lavage and pleural brushing in cases of undiagnosed exudative pleural effusion.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients will have documented exudative pleural effusion in whom the initial pleural tapping and closed pleural biopsy (CPB) will not be conclusive

• strong clinical and radiological data suggestive for alternative pathological diagnosis

• who will be admitted to our department

Exclusion Criteria:

• Patients with excess rib crowding with narrow inter-costal space and loculated pleural effusion cannot undergo thoracoscopy

• Patients with bleeding diathesis

• hemodynamic instability

• Arrhythmias

• intractable cough cannot be eligible to do thoracoscopy

Related Conditions & MeSH terms

• Disorder of Pleura and Pleural Cavity
• Pleural Diseases
• Pleural Effusion

Intervention

Procedure:
• medical thoracoscope
Medical thoracoscopy will be performed during which pleural brush will be used first followed by forceps biopsy to obtain pleural specimens from suspect areas under visual control and pleural lavage will be performed by injecting 300 mL of normal saline

Diagnostic Test:
• Forceps biopsy and pleural brush histopathology
Forceps biopsy and pleural brush will be obtained for histopathological examination for diagnosis
• pleural lavage cytology
pleural lavage will be obtained for cytological examination for diagnosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Bejui-Thivolet F, Guerin JC, Salle M, Milox A, Champel F, Vitrey D. [Contribution of thoracoscopic brushing to the diagnosis of pleural diseases]. Ann Pathol. 1984 Jun-Aug;4(3):195-201. French. — View Citation

Bejui-Thivolet F, Guerin JC, Salle M, Milox A, Champel F, Vitrey D. [Thoracoscopy with pleural brushing. A new diagnostic method for pleural diseases]. Rev Pneumol Clin. 1984;40(5):311-9. French. — View Citation

Blanc FX, Atassi K, Bignon J, Housset B. Diagnostic value of medical thoracoscopy in pleural disease: a 6-year retrospective study. Chest. 2002 May;121(5):1677-83. doi: 10.1378/chest.121.5.1677. — View Citation

Mohamed KH, Mobasher AA, Yousef AI, Salah A, Ramadan MA, Emam AK, Alhayawan HM, Light RW. Pleural lavage: a novel diagnostic approach for diagnosing exudative pleural effusion. Lung. 2000 Nov-Dec;178(6):371-9. doi: 10.1007/s004080000040. — View Citation

Sivagnaname Y-, Radhakrishnan P, Maria Selvam A. Thoracoscopic pleural brushing - an innovative method of pleural sampling in diagnostic medical thoracoscopy. Adv Respir Med. 2019;87(5):257-260. doi: 10.5603/ARM.2019.0046. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of efficacy which determined by the diagnostic yield	comparing thoracoscopic forceps biopsy, pleural brush and pleural lavage as regard efficacy which determined by the diagnostic yield	Baseline
Secondary	Evaluation of safety which determined by occurance of complications	comparing thoracoscopic forceps biopsy, pleural brush and pleural lavage as regard safety which determined by occurance of complications	Baseline