NCT03805971 · OUTCOME
Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis. · Source last updated 2020-04-03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- One day.
What was measured
Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
Groups in this outcome
Benign Pleura
Participants with a benign pleura histological diagnosis.
Malignant Pleural Infiltrations
Participants with a malignant pleural disease demonstrated by biopsies.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Benign Pleura | 36 |
|---|
| Malignant Pleural Infiltrations | 26 |
|---|
Reported measurements
Abnormal tissular architecture
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Not assessable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Cellular size homogeneity
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
Not assessable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Cellular shape homogeneity
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Not assessable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Cellular fluorescence homogeneity
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Not assessable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Blood vessels dysplasia
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Not assessable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Organized connective tissue
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Not assessable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Chia seed sign
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
Not assessable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Benign Pleura | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Malignant Pleural Infiltrations | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- group Description
- The objective of the test is to assess if the pCLE feature "full chia seed sign" is found statistically more frequently in the "benign pleura group" than in the "malignant pleural infiltrations group".
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- statistical Method
- Fisher Exact
- group Description
- The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the "malignant pleural infiltrations group" than in the "benign pleura group".
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- group Description
- The objective is to assess if the pCLE feature "cellular shape homogeneity" is found statistically more frequently in the "benign pleura group" than in the "malignant pleural infiltrations group".
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0052
- statistical Method
- Fisher Exact
- group Description
- The objective is to assess if dysplastic vessels are more frequently found in the "malignant pleural infiltrations group" than in the "benign pleura group".
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Description
- The objective of the test is to assess if the pCLE feature "full chia seed sign" is found statistically more frequently in the "benign pleura group" than in the "malignant pleural infiltrations group".
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- statistical Method
- Fisher Exact
- group Description
- The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the "malignant pleural infiltrations group" than in the "benign pleura group".
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- group Description
- The objective is to assess if the pCLE feature "cellular shape homogeneity" is found statistically more frequently in the "benign pleura group" than in the "malignant pleural infiltrations group".
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0052
- statistical Method
- Fisher Exact
- group Description
- The objective is to assess if dysplastic vessels are more frequently found in the "malignant pleural infiltrations group" than in the "benign pleura group".
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 24
- title
- Yes
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 0
- title
- No
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- title
- Not assessable
- title
- Abnormal tissular architecture
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 7
- title
- Yes
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 16
- title
- No
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- title
- Not assessable
- title
- Cellular size homogeneity
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 4
- title
- Yes
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 19
- title
- No
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- title
- Not assessable
- title
- Cellular shape homogeneity
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 14
- title
- Yes
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 10
- title
- No
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Not assessable
- title
- Cellular fluorescence homogeneity
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 17
- title
- Yes
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 3
- title
- No
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- title
- Not assessable
- title
- Blood vessels dysplasia
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 5
- title
- Yes
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 12
- title
- No
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 9
- title
- Not assessable
- title
- Organized connective tissue
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 0
- title
- Yes
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 26
- title
- No
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Not assessable
- title
- Chia seed sign
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 26
- units
- Participants
- description
- Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
- groups
- description
- Participants with a benign pleura histological diagnosis.
- id
- OG000
- title
- Benign Pleura
- description
- Participants with a malignant pleural disease demonstrated by biopsies.
- id
- OG001
- title
- Malignant Pleural Infiltrations
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- One day.
- title
- Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
- type
- PRIMARY
- unit Of Measure
- Participants
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