NCT06066398

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 6, 2023

Last Update Submit

September 27, 2023

Conditions

Disorder of Pleura and Pleural Cavity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of safety which determined by occurance of complications

    Baseline

Study Arms (1)

medical thoracoscope

OTHER

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

Procedure: medical thoracoscopeDiagnostic Test: Forceps biopsy and pleural brush histopathologyDiagnostic Test: pleural lavage cytology

Interventions

medical thoracoscopePROCEDURE

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

medical thoracoscope
Forceps biopsy and pleural brush histopathologyDIAGNOSTIC_TEST

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

medical thoracoscope
pleural lavage cytologyDIAGNOSTIC_TEST

pleural lavage will be obtained for cytological examination for diagnosis

medical thoracoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 31680224BACKGROUND

  • 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.

    PMID: 6522932BACKGROUND

  • 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.

    PMID: 6089845BACKGROUND

  • 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.

    PMID: 12006460BACKGROUND

  • 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.

    PMID: 11361060BACKGROUND

MeSH Terms

Conditions

Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Amira Emad El-din

CONTACT

01019937498tota_eg1993@yahoo.com

yousef Ahmed

CONTACT

01025033083Yousefahmad72@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: single group will be undergone thoracoscopy where pleural forceps biopsy, pleural brush and pleural lavage will be taken
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 6, 2023

First Posted

October 4, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

October 4, 2023

Record last verified: 2023-09