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Thoracoscopic Pleural Lavage and Brushing in Undiagnosed Pleural Effusion

Primary Purpose

Disorder of Pleura and Pleural Cavity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
medical thoracoscope
Forceps biopsy and pleural brush histopathology
pleural lavage cytology
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Disorder of Pleura and Pleural Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    medical thoracoscope

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    September 27, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06066398
    Brief Title
    Thoracoscopic Pleural Lavage and Brushing in Undiagnosed Pleural Effusion
    Official Title
    Evaluation of Thoracoscopic Pleural Lavage and Pleural Brushing as Unconventional Methods for Diagnosis of Pleural Effusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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: The cells in the lavage are fresher and have not undergone degeneration as have many cells in the pleural fluid. 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. Biopsies of the parietal and visceral pleura could have exposed the tumor and allowed malignant cells to be shed into the lavage fluid.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disorder of Pleura and Pleural Cavity

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    single group will be undergone thoracoscopy where pleural forceps biopsy, pleural brush and pleural lavage will be taken
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    medical thoracoscope
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    medical thoracoscope
    Intervention Description
    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
    Diagnostic Test
    Intervention Name(s)
    Forceps biopsy and pleural brush histopathology
    Intervention Description
    Forceps biopsy and pleural brush will be obtained for histopathological examination for diagnosis
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    pleural lavage cytology
    Intervention Description
    pleural lavage will be obtained for cytological examination for diagnosis
    Primary Outcome Measure Information:
    Title
    Measurement of efficacy which determined by the diagnostic yield
    Description
    comparing thoracoscopic forceps biopsy, pleural brush and pleural lavage as regard efficacy which determined by the diagnostic yield
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    Evaluation of safety which determined by occurance of complications
    Description
    comparing thoracoscopic forceps biopsy, pleural brush and pleural lavage as regard safety which determined by occurance of complications
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amira Emad El-din
    Phone
    01019937498
    Ext
    +2
    Email
    tota_eg1993@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    yousef Ahmed
    Phone
    01025033083
    Ext
    +2
    Email
    Yousefahmad72@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31680224
    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.
    Results Reference
    background
    PubMed Identifier
    6522932
    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.
    Results Reference
    background
    PubMed Identifier
    6089845
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12006460
    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.
    Results Reference
    background
    PubMed Identifier
    11361060
    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.
    Results Reference
    background

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    Thoracoscopic Pleural Lavage and Brushing in Undiagnosed Pleural Effusion

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