Thoracoscopic Pleural Lavage and Brushing in Undiagnosed Pleural Effusion

NCT ID: NCT06066398

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Disorder of Pleura and Pleural Cavity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group will be undergone thoracoscopy where pleural forceps biopsy, pleural brush and pleural lavage will be taken
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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medical thoracoscope

medical thoracoscope will be done during which pleural brush, pleural forceps biopsy and pleural lavage will be taken to compare yield of diagnosis and safety between them

Group Type OTHER

medical thoracoscope

Intervention Type PROCEDURE

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

Forceps biopsy and pleural brush histopathology

Intervention Type DIAGNOSTIC_TEST

Forceps biopsy and pleural brush will be obtained for histopathological examination for diagnosis

pleural lavage cytology

Intervention Type DIAGNOSTIC_TEST

pleural lavage will be obtained for cytological examination for diagnosis

Interventions

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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

Intervention Type PROCEDURE

Forceps biopsy and pleural brush histopathology

Forceps biopsy and pleural brush will be obtained for histopathological examination for diagnosis

Intervention Type DIAGNOSTIC_TEST

pleural lavage cytology

pleural lavage will be obtained for cytological examination for diagnosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amira Emad El-din Abdalah

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amira Emad El-din

Role: CONTACT

01019937498 ext. +2

yousef Ahmed

Role: CONTACT

01025033083 ext. +2

References

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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.

Reference Type BACKGROUND
PMID: 31680224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6522932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6089845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12006460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11361060 (View on PubMed)

Other Identifiers

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Thoraco pleural lavage & brush

Identifier Type: -

Identifier Source: org_study_id

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