Trial Outcomes & Findings for Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis. (NCT NCT03805971)
NCT ID: NCT03805971
Last Updated: 2020-04-03
Results Overview
Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
Recruitment status
COMPLETED
Target enrollment
65 participants
Primary outcome timeframe
One day.
Results posted on
2020-04-03
Participant Flow
Participant milestones
| Measure |
Patient Aged More Than 18 Years Admitted for Thoracoscopy
Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies
Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Patient Aged More Than 18 Years Admitted for Thoracoscopy
Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies
Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patient Aged More Than 18 Years Admitted for Thoracoscopy
n=62 Participants
Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies
Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.
|
|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 17.29 • n=62 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=62 Participants
|
|
Thoracoscopy indication
Talc pleurodesis for recurrent pneumothorax
|
8 Participants
n=62 Participants
|
|
Thoracoscopy indication
Pleural exudation management (mainly lymphocytic)
|
46 Participants
n=62 Participants
|
|
Thoracoscopy indication
Talc pleurodesis for recurrent malignant effusion
|
4 Participants
n=62 Participants
|
|
Thoracoscopy indication
Pleural hyper metabolism on TEP
|
2 Participants
n=62 Participants
|
|
Thoracoscopy indication
Pleural nodularity on CT-scan
|
2 Participants
n=62 Participants
|
|
Final histological diagnosis
Normal pleura
|
7 Participants
n=62 Participants
|
|
Final histological diagnosis
(Sub-)acute pleuritis
|
15 Participants
n=62 Participants
|
|
Final histological diagnosis
Chronic pleuritis
|
13 Participants
n=62 Participants
|
|
Final histological diagnosis
Pulmonary adenocarcinoma
|
9 Participants
n=62 Participants
|
|
Final histological diagnosis
Malignant mesothelioma
|
7 Participants
n=62 Participants
|
|
Final histological diagnosis
Large cell lymphoma
|
2 Participants
n=62 Participants
|
|
Final histological diagnosis
Small cell lung carcinoma
|
3 Participants
n=62 Participants
|
|
Final histological diagnosis
Squamous cell lung carcinoma
|
3 Participants
n=62 Participants
|
|
Final histological diagnosis
Breast adenocarcinoma
|
1 Participants
n=62 Participants
|
|
Final histological diagnosis
Urothelial Carcinoma
|
1 Participants
n=62 Participants
|
|
Final histological diagnosis
Sarcoidosi
|
1 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: One day.Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
Outcome measures
| Measure |
Benign Pleura
n=36 Participants
Participants with a benign pleura histological diagnosis.
|
Malignant Pleural Infiltrations
n=26 Participants
Participants with a malignant pleural disease demonstrated by biopsies.
|
|---|---|---|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Abnormal tissular architecture · Yes
|
8 Participants
|
24 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Abnormal tissular architecture · No
|
21 Participants
|
0 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Abnormal tissular architecture · Not assessable
|
7 Participants
|
2 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular size homogeneity · Yes
|
18 Participants
|
7 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular size homogeneity · No
|
14 Participants
|
16 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular size homogeneity · Not assessable
|
4 Participants
|
3 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular shape homogeneity · Yes
|
18 Participants
|
4 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular shape homogeneity · No
|
14 Participants
|
19 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular shape homogeneity · Not assessable
|
4 Participants
|
3 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular fluorescence homogeneity · Yes
|
28 Participants
|
14 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular fluorescence homogeneity · No
|
7 Participants
|
10 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Cellular fluorescence homogeneity · Not assessable
|
1 Participants
|
2 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Blood vessels dysplasia · Yes
|
8 Participants
|
17 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Blood vessels dysplasia · No
|
23 Participants
|
3 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Blood vessels dysplasia · Not assessable
|
5 Participants
|
6 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Organized connective tissue · Yes
|
11 Participants
|
5 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Organized connective tissue · No
|
20 Participants
|
12 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Organized connective tissue · Not assessable
|
5 Participants
|
9 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Chia seed sign · Yes
|
13 Participants
|
0 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Chia seed sign · No
|
23 Participants
|
26 Participants
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Chia seed sign · Not assessable
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: Some criteria were not assessable for some patients.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Here are presented Mean cell size and maximum vascular diameter
Outcome measures
| Measure |
Benign Pleura
n=36 Participants
Participants with a benign pleura histological diagnosis.
|
Malignant Pleural Infiltrations
n=26 Participants
Participants with a malignant pleural disease demonstrated by biopsies.
|
|---|---|---|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Mean cell size
|
21.76 µm
Standard Deviation 5.69
|
22.96 µm
Standard Deviation 5.16
|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
Maximal vascular diameter
|
22.72 µm
Standard Deviation 9.93
|
27.08 µm
Standard Deviation 8.91
|
PRIMARY outcome
Timeframe: One dayPopulation: Some criteria were not assessable for some patients.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Quantitative criteria are presented in this table. Here is presented the mean cellular density
Outcome measures
| Measure |
Benign Pleura
n=36 Participants
Participants with a benign pleura histological diagnosis.
|
Malignant Pleural Infiltrations
n=26 Participants
Participants with a malignant pleural disease demonstrated by biopsies.
|
|---|---|---|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
|
25.42 number of cells/10^4µm^2
Standard Deviation 8.73
|
22.01 number of cells/10^4µm^2
Standard Deviation 7.35
|
PRIMARY outcome
Timeframe: One dayPopulation: Some criteria were not assessable for some patients.
Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura. Quantitative criteria are presented in this table. Here is presented the vascular density.
Outcome measures
| Measure |
Benign Pleura
n=36 Participants
Participants with a benign pleura histological diagnosis.
|
Malignant Pleural Infiltrations
n=26 Participants
Participants with a malignant pleural disease demonstrated by biopsies.
|
|---|---|---|
|
Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
|
9.81 Vessels/1.13 mm^2 (full optic area)
Standard Deviation 7.73
|
6.9 Vessels/1.13 mm^2 (full optic area)
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: One dayThe investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.
Outcome measures
| Measure |
Benign Pleura
n=36 Participants
Participants with a benign pleura histological diagnosis.
|
Malignant Pleural Infiltrations
n=26 Participants
Participants with a malignant pleural disease demonstrated by biopsies.
|
|---|---|---|
|
Quality of the pCLE Acquisition
Good
|
12 Participants
|
8 Participants
|
|
Quality of the pCLE Acquisition
Acceptable
|
13 Participants
|
9 Participants
|
|
Quality of the pCLE Acquisition
Low
|
11 Participants
|
9 Participants
|
Adverse Events
Patient Aged More Than 18 Years Admitted for Thoracoscopy
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: 003243667881
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place