Trial Outcomes & Findings for ENB-GS-TBLB for the Diagnosis of PPLs (NCT NCT02207478)
NCT ID: NCT02207478
Last Updated: 2015-11-30
Results Overview
The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Up to half year
Results posted on
2015-11-30
Participant Flow
Participant milestones
| Measure |
ENB-GS-TBLB-X-ray Group
The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System.
ENB: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
|
GS-TBLB-X-ray Group
The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
46
|
|
Overall Study
COMPLETED
|
40
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ENB-GS-TBLB for the Diagnosis of PPLs
Baseline characteristics by cohort
| Measure |
ENB-GS-TBLB-X-ray Group
n=39 Participants
The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
|
GS-TBLB-X-ray Group
n=41 Participants
The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.28 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
59.32 years
STANDARD_DEVIATION 9.57 • n=7 Participants
|
60.28 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
lesion size(long axis)
|
29.7 mm
STANDARD_DEVIATION 11 • n=5 Participants
|
33.07 mm
STANDARD_DEVIATION 13.8 • n=7 Participants
|
31.39 mm
STANDARD_DEVIATION 12.51 • n=5 Participants
|
|
lesion size(short axis)
|
21.64 mm
STANDARD_DEVIATION 10.42 • n=5 Participants
|
22.28 mm
STANDARD_DEVIATION 10.66 • n=7 Participants
|
21.96 mm
STANDARD_DEVIATION 10.47 • n=5 Participants
|
|
lesion location
Upper Lobes
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
lesion location
Middle Lobes
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
lesion location
Lower lobes
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
distance from the lesion to the pleural
|
15.53 mm
STANDARD_DEVIATION 14.79 • n=5 Participants
|
20.99 mm
STANDARD_DEVIATION 16.08 • n=7 Participants
|
18.19 mm
STANDARD_DEVIATION 15.57 • n=5 Participants
|
|
bronchus sign
Yes
|
32 participants
n=5 Participants
|
38 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
bronchus sign
No
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to half yearThe diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.
Outcome measures
| Measure |
ENB-GS-TBLB-X-ray Group
n=39 Participants
The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
|
GS-TBLB-X-ray Group
n=41 Participants
The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
|
|---|---|---|
|
The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
Diagnosed by TBLB
|
34 participants
|
25 participants
|
|
The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
Not Diagnosed by TBLB
|
5 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Up to half yearIncluding total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.
Outcome measures
| Measure |
ENB-GS-TBLB-X-ray Group
n=39 Participants
The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
|
GS-TBLB-X-ray Group
n=41 Participants
The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
|
|---|---|---|
|
The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone
Total X-ray time
|
156.56 seconds
Standard Deviation 94.03
|
142.27 seconds
Standard Deviation 111.84
|
|
The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone
Duration time for finding lesion
|
126.74 seconds
Standard Deviation 128.80
|
224.98 seconds
Standard Deviation 119.08
|
|
The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone
Total procedure time
|
1053.6 seconds
Standard Deviation 408.6
|
1056.6 seconds
Standard Deviation 387
|
|
The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone
X-ray time for finding lesion
|
7.21 seconds
Standard Deviation 7.79
|
38.88 seconds
Standard Deviation 39.37
|
Adverse Events
ENB-GS-TBLB-X-ray Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GS-TBLB-X-ray Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place