Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis

NCT04731129 | Completed Results

• 1 other identifier: 2018-192
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, probe based confocal laser endomicroscopy showed to be able to distinguish malignant from benign pleura during medical thoracoscopy. However The clinical usefulness of this new tool remains to be determined. The investigators believe that pCLE could be part of mini invasive pleural disease management and could be used during thoracentesis in order to increase the diagnostic yield of this procedure. The investigators are starting a prospective trial to recruit patients referred for medical thoracoscopy to the endoscopy unit. First, the pCLE probe will be introduced through the Boutin's needle or the thoracentesis catheter, just before the thoracoscopy, in order to investigate the pleural pCLE features and to identify or exclude malignant infiltration. Second those features will be compared to the pCLE acquisition obtained during the medical thoracoscopy (the probe is introduced through the working chanel of the thoracoscope), under visual control. In order to compare the invasive and mini invasive acquisition, 10 criteria will be prospectively assessed.Third, These features will be compared to the histological samples performed during thoracoscopy. Finally, the interpretation of different investigators will be compared. The 10 criteria are presented below:

1. 1.Abnormal tissular architecture
2. 2.Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator
3. 3.Mean cellular size:
4. 4.Cellular density (with reference to the Chia seed sign)
5. 5.Dysplastic vessels:
6. 6.Vascular density (on a full optical area)
7. 7.Organized or anarchic connective fibers
8. 8.Chia seed sign on a full optical areal

Conditions

Pleural Diseases; Pleural Neoplasms

Keywords

Probe based confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (3)

• Malignant Pleural Infiltration Identification

  Before medical thoracoscopy, the laser endomicroscopy probe will be introduced through the Boutin's needle or the thoracentesis catheter. The pleural probe based confocal laser endomicroscopy acquisition will be assessed by two experienced and unblinded clinicians (aware of the medical history of the patient) during the procedure. The objective is to determine if the preselected criteria are present with significantly different frequencies in malignant adn in benign pleural involvement.

  one day

• Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment.

  Every (Serious)adverse event will be reported during the intervention or during post intervention surveillance (1 hour post intervention). The feasibility will be assessed by comparing the images from the mini invasive phase with this from the invasive phase.

  One day

• Pleural Fluid Cytological Analysis

  Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies.

  one day

Interventions

Probe based confocal laser endomicroscopy of the pleura DEVICE

Every patient referred for medical thoracoscopy will be screened. The pCLE of the pleura will be performed 2 times. First, just before the thoracoscopy, through the Boutin's needle or the thoracentesis catheter and second through the working chanel of the pleuroscope. This last acquisition allows visual control to target the pleural endomicroscopy assessment. These two acquisitions will be compared between each other and with the histological samples of the pleuroscopy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every patient referred to the endoscopy unit for medical thoracoscopy

You may qualify if:

• Every patient referred to the endoscopy unit for medical thoracoscopy

You may not qualify if:

• Pregnancy
• Known allergy to the fluorescein

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Olivier Bonhomme

Liège, 4020, Belgium

Location

MeSH Terms

Conditions

Pleural Diseases; Pleural Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr Olivier Bonhomme
• Organization: Centre hospitalier universitaire de liège

obonhomme@chuliege.be

003243239580

Study Officials

• Duysinx Bernard, PhD

  University of Liege

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic in pulmonary medicine

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 29, 2021
• Study Start: December 15, 2020
• Primary Completion: September 15, 2023
• Study Completion: November 30, 2023
• Last Updated: January 10, 2025
• Results First Posted: January 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)