Lung Cancer
Conditions
Keywords
Electromagnetic navigation bronchoscopy with a guide sheath, Transbronchial lung biopsy, Peripheral lung lesions, Solitary pulmonary nodule
Brief summary
The purpose of this study is to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) .
Detailed description
The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope department, Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University, China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray group.Each subject will be randomized to each group.The study is expected to enroll 60 patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).
Interventions
PROCEDUREENB
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.
PROCEDUREGS-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.
Sponsors
Fudan University
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. clinical and imaging characteristics suggestive of maligancy 2. CT scan appearance of the PPLs showed the longest diameter was more than 1 cm and solid lesions.
Exclusion criteria
1. The lesion is close to the pleural membrane 2. Refusal of participation 3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB | Up to half year | The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone | Up to half year | Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ENB-GS-TBLB-X-ray Group 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. | 39 |
| 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. | 41 |
| Total | 80 |
Baseline characteristics
| Characteristic | ENB-GS-TBLB-X-ray Group | GS-TBLB-X-ray Group | Total |
|---|---|---|---|
| Age, Continuous | 61.28 years STANDARD_DEVIATION 7.61 | 59.32 years STANDARD_DEVIATION 9.57 | 60.28 years STANDARD_DEVIATION 8.67 |
| bronchus sign No | 7 participants | 3 participants | 10 participants |
| bronchus sign Yes | 32 participants | 38 participants | 70 participants |
| distance from the lesion to the pleural | 15.53 mm STANDARD_DEVIATION 14.79 | 20.99 mm STANDARD_DEVIATION 16.08 | 18.19 mm STANDARD_DEVIATION 15.57 |
| lesion location Lower lobes | 10 participants | 11 participants | 21 participants |
| lesion location Middle Lobes | 3 participants | 1 participants | 4 participants |
| lesion location Upper Lobes | 26 participants | 29 participants | 55 participants |
| lesion size(long axis) | 29.7 mm STANDARD_DEVIATION 11 | 33.07 mm STANDARD_DEVIATION 13.8 | 31.39 mm STANDARD_DEVIATION 12.51 |
| lesion size(short axis) | 21.64 mm STANDARD_DEVIATION 10.42 | 22.28 mm STANDARD_DEVIATION 10.66 | 21.96 mm STANDARD_DEVIATION 10.47 |
| Sex: Female, Male Female | 19 Participants | 14 Participants | 33 Participants |
| Sex: Female, Male Male | 20 Participants | 27 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 41 |
| serious Total, serious adverse events | 0 / 39 | 0 / 41 |
Outcome results
Primary
The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.
Time frame: Up to half year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ENB-GS-TBLB-X-ray Group | The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB | Not Diagnosed by TBLB | 5 participants |
| ENB-GS-TBLB-X-ray Group | The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB | Diagnosed by TBLB | 34 participants |
| GS-TBLB-X-ray Group | The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB | Diagnosed by TBLB | 25 participants |
| GS-TBLB-X-ray Group | The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB | Not Diagnosed by TBLB | 16 participants |
p-value: 0.019Cochran-Mantel-Haenszel
Secondary
The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone
Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.
Time frame: Up to half year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ENB-GS-TBLB-X-ray Group | 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 |
| ENB-GS-TBLB-X-ray Group | 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 |
| ENB-GS-TBLB-X-ray Group | 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 128.8 |
| ENB-GS-TBLB-X-ray Group | 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 |
| GS-TBLB-X-ray Group | The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone | X-ray time for finding lesion | 38.88 seconds | Standard Deviation 39.37 |
| GS-TBLB-X-ray Group | The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone | Duration time for finding lesion | 224.98 seconds | Standard Deviation 119.08 |
| GS-TBLB-X-ray Group | The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone | Total procedure time | 1056.6 seconds | Standard Deviation 387 |
| GS-TBLB-X-ray Group | The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone | Total X-ray time | 142.27 seconds | Standard Deviation 111.84 |
Comparison: Total procedure timep-value: 0.843Wilcoxon (Mann-Whitney)
Comparison: Total X-ray timep-value: 0.233Wilcoxon (Mann-Whitney)
Comparison: Duration time for finding lesionsp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: X-ray time for finding lesionsp-value: <0.001Wilcoxon (Mann-Whitney)