Trial Outcomes & Findings for Mini Invasive Endomicroscopy of the Pleura for Malignancies Diagnosis (NCT NCT04731129)

Last Updated: 2025-01-10

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

59 participants

Primary outcome timeframe

one day

Results posted on

2025-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion Every patient referred to medical thoracoscopy for pleural effusion treatment or workup. exclusion criteria are age\< 18; Pregnancy; Known allergy to fluorescein
Overall Study STARTED	59
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

8 patients unwilling to participate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Referred to Medical Throacoscopy for Treatment or Exploration of a Pleural Effusion n=52 Participants Every patient referred to medical thoracoscopy for pleural effusion treatment or workup. exclusion criteria are age\< 18; Pregnancy; Known allergy to fluorescein
Age, Continuous	67 years STANDARD_DEVIATION 8.5 • n=52 Participants • 8 patients unwilling to participate
Sex: Female, Male Female	24 Participants n=52 Participants
Sex: Female, Male Male	28 Participants n=52 Participants
Region of Enrollment Belgium	52 participants n=52 Participants

PRIMARY outcome

Timeframe: one day

Outcome measures

Outcome measures
Measure	Patietns With a Pleural Biopsy Histology of Benign Disease n=21 Participants Every patients had pleural biopsies to conclude the thoracoscopy. This group gather patients with a benign pleural effusion according to pleural biopsies	Patients With a Malignant Pleural Biopsy Histology n=31 Participants Every patient included had pleural biopsies at the end of the medical thoracoscopy. This group gathers patients with a malignant pleural effusion according to pleural biopsies.
Malignant Pleural Infiltration Identification Blood vessel dysplasia · No	12 Participants	11 Participants
Malignant Pleural Infiltration Identification Abnormal tissular architecture · Yes	12 Participants	27 Participants
Malignant Pleural Infiltration Identification Abnormal tissular architecture · No	9 Participants	4 Participants
Malignant Pleural Infiltration Identification Homogeneous cell size · Yes	15 Participants	10 Participants
Malignant Pleural Infiltration Identification Homogeneous cell size · No	6 Participants	21 Participants
Malignant Pleural Infiltration Identification Homogeneous cell shape · Yes	15 Participants	10 Participants
Malignant Pleural Infiltration Identification Homogeneous cell shape · No	6 Participants	21 Participants
Malignant Pleural Infiltration Identification Homogeneous cell fluorescence · Yes	11 Participants	7 Participants
Malignant Pleural Infiltration Identification Homogeneous cell fluorescence · No	10 Participants	24 Participants
Malignant Pleural Infiltration Identification Blood vessel dysplasia · Yes	9 Participants	20 Participants
Malignant Pleural Infiltration Identification Organized conjunctive fibers · Yes	19 Participants	23 Participants
Malignant Pleural Infiltration Identification Organized conjunctive fibers · No	2 Participants	8 Participants
Malignant Pleural Infiltration Identification Full Chia seed sign · Yes	6 Participants	2 Participants
Malignant Pleural Infiltration Identification Full Chia seed sign · No	15 Participants	29 Participants
Malignant Pleural Infiltration Identification General physician conclusion · Yes	10 Participants	27 Participants
Malignant Pleural Infiltration Identification General physician conclusion · No	11 Participants	4 Participants

PRIMARY outcome

Timeframe: One day

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.

Outcome measures

Outcome measures
Measure	Patietns With a Pleural Biopsy Histology of Benign Disease n=52 Participants Every patients had pleural biopsies to conclude the thoracoscopy. This group gather patients with a benign pleural effusion according to pleural biopsies	Patients With a Malignant Pleural Biopsy Histology Every patient included had pleural biopsies at the end of the medical thoracoscopy. This group gathers patients with a malignant pleural effusion according to pleural biopsies.
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Abnormal tissular architecture · concordant	49 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Abnormal tissular architecture · non concordant	3 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Homogeneous cell shape · concordant	50 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Homogeneous cell shape · non concordant	2 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Homogeneous cell fluorescence · concordant	50 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Homogeneous cell fluorescence · non concordant	2 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Homogeneous cell size · concordant	50 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Homogeneous cell size · non concordant	2 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Full chia seed sign · concordant	52 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. Full chia seed sign · non concordant	0 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. General physician conclusion · concordant	52 Participants	—
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment. General physician conclusion · non concordant	0 Participants	—

PRIMARY outcome

Timeframe: one day

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

Outcome measures

Outcome measures
Measure	Patietns With a Pleural Biopsy Histology of Benign Disease n=21 Participants Every patients had pleural biopsies to conclude the thoracoscopy. This group gather patients with a benign pleural effusion according to pleural biopsies	Patients With a Malignant Pleural Biopsy Histology n=31 Participants Every patient included had pleural biopsies at the end of the medical thoracoscopy. This group gathers patients with a malignant pleural effusion according to pleural biopsies.
Pleural Fluid Cytological Analysis Benign fluid cytology	21 Participants	18 Participants
Pleural Fluid Cytological Analysis malignant pleural fluid cytology	0 Participants	13 Participants

Adverse Events

The Entire Studied Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Olivier Bonhomme

Centre hospitalier universitaire de liège

Phone: 003243239580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place