Thoracoscopic Pleural Lavage and Brushing in Undiagnosed Pleural Effusion

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06066398
Collaborator
(none)
60
1
24

Study Details

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.
Condition or Disease Intervention/Treatment Phase
  • Procedure: medical thoracoscope
  • Diagnostic Test: Forceps biopsy and pleural brush histopathology
  • Diagnostic Test: pleural lavage cytology
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single group will be undergone thoracoscopy where pleural forceps biopsy, pleural brush and pleural lavage will be takensingle group will be undergone thoracoscopy where pleural forceps biopsy, pleural brush and pleural lavage will be taken
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Thoracoscopic Pleural Lavage and Pleural Brushing as Unconventional Methods for Diagnosis of Pleural Effusion
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: 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

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

Diagnostic Test: pleural lavage cytology
pleural lavage will be obtained for cytological examination for diagnosis

Outcome Measures

Primary Outcome Measures

  1. Measurement of efficacy which determined by the diagnostic yield [Baseline]

    comparing thoracoscopic forceps biopsy, pleural brush and pleural lavage as regard efficacy which determined by the diagnostic yield

Secondary Outcome Measures

  1. Evaluation of safety which determined by occurance of complications [Baseline]

    comparing thoracoscopic forceps biopsy, pleural brush and pleural lavage as regard safety which determined by occurance of complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amira Emad El-din Abdalah, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06066398
Other Study ID Numbers:
  • Thoraco pleural lavage & brush
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2023