Lung Neoplasm, Thoracic Surgery, Video-Assisted
Conditions
Keywords
Printing, Three-dimensional
Brief summary
The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.
Detailed description
Localization of small lung nodule is challenging due to the difficulty of nodule recognition during VATS. A three-dimensional printed navigational template was designed to aid percutaneous lung nodule localization, and its feasibility has been confirmed in previous study. The trial was conducted to confirm the non-inferiority of template-guided method to conventional CT-guided method in terms of localization accuracy.
Interventions
DEVICEtemplate-guided localization
Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization.
OTHERCT-guided localization
Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
Sponsors
Chang Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged from 19 to 80 years 2. lesions located in peripheral lung tissue which can be removed by wedge resection 3. The maximum diameter of the lesion is no more than 20 mm. 4. Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization 5. Informed consent was signed voluntarily.
Exclusion criteria
1. nodule located in the scapula region. 2. there were two or more lung nodules needed to be localized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Lung Nodule Localization | From the time of completing final CT scan, assessed up to 2 days. | Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Duration of the Nodule Localization | From the time of completing final CT scan, assessed up to 1 hour. | Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan. |
| Radiation Dose | From the time of completing final CT scan, assessed up to 1 hour. | Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage. |
| Complication Rate | From the time of completing final CT scan, assessed up to 2 days. | Pnuemothorax related to lung nodule localization |
Countries
China
Participant flow
Recruitment details
The recruitment process was from October 15, 2016 to October 26, 2017. And, the first participant was recruited on October 24, 2016. Until reaching to 40% of prespecified sample size (Janunary 1, 2017) , interim analysis was conducted.
Participants by arm
| Arm | Count |
|---|---|
| CT-guided Localization This group of participants received conventional CT-guided lung nodule localization.
CT-guided localization: Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization. | 100 |
| Template-guided Localization Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
template-guided localization: Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization. | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | CT-guided Localization | Template-guided Localization | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 11 | 54 years STANDARD_DEVIATION 15 | 53 years STANDARD_DEVIATION 13 |
| BMI(body mass index) | 22.9 Kg/m^2 STANDARD_DEVIATION 2.9 | 22.8 Kg/m^2 STANDARD_DEVIATION 2.8 | 22.9 Kg/m^2 STANDARD_DEVIATION 2.8 |
| Distance from pleura | 6.5 mm | 8.5 mm | 7.8 mm |
| FEV1（of percentage predicted） | 93.6 Percentage predicted FEV1 STANDARD_DEVIATION 13 | 94.3 Percentage predicted FEV1 STANDARD_DEVIATION 14.6 | 94.0 Percentage predicted FEV1 STANDARD_DEVIATION 13.8 |
| Nodule location left lower lobe(LLL) | 17 Participants | 15 Participants | 32 Participants |
| Nodule location left upper lobe(LUL) | 22 Participants | 25 Participants | 47 Participants |
| Nodule location right lower lobe(RLL) | 26 Participants | 17 Participants | 43 Participants |
| Nodule location right middle lobe(RML) | 9 Participants | 5 Participants | 14 Participants |
| Nodule location right upper lobe(RUL) | 26 Participants | 38 Participants | 64 Participants |
| Nodule size | 9.2 mm STANDARD_DEVIATION 2.7 | 10.1 mm STANDARD_DEVIATION 3 | 9.7 mm STANDARD_DEVIATION 2.9 |
| Nodule type Mixed ground glass opacity(GGO) | 35 Participants | 50 Participants | 85 Participants |
| Nodule type pure ground glass opacity(GGO) | 55 Participants | 41 Participants | 96 Participants |
| Nodule type Solid | 10 Participants | 9 Participants | 19 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 73 Participants | 74 Participants | 147 Participants |
| Sex: Female, Male Male | 27 Participants | 26 Participants | 53 Participants |
| Smoking history NO | 72 Participants | 70 Participants | 142 Participants |
| Smoking history YES | 28 Participants | 30 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 95 |
| other Total, other adverse events | 28 / 95 | 16 / 95 |
| serious Total, serious adverse events | 0 / 95 | 0 / 95 |
Outcome results
Primary
Accuracy of Lung Nodule Localization
Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)
Time frame: From the time of completing final CT scan, assessed up to 2 days.
Population: Modified Intention-to-treat analysis (patients who did not receive lung nodule localization were excluded.(n=10))
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-guided Localization | Accuracy of Lung Nodule Localization | 9.6 mm | Standard Deviation 5.8 |
| Template-guided Localization | Accuracy of Lung Nodule Localization | 8.7 mm | Standard Deviation 6.9 |
Secondary
Complication Rate
Pnuemothorax related to lung nodule localization
Time frame: From the time of completing final CT scan, assessed up to 2 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-guided Localization | Complication Rate | 17 Participants |
| Template-guided Localization | Complication Rate | 10 Participants |
Secondary
Procedural Duration of the Nodule Localization
Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan.
Time frame: From the time of completing final CT scan, assessed up to 1 hour.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-guided Localization | Procedural Duration of the Nodule Localization | 9.5 min | Standard Deviation 3.6 |
| Template-guided Localization | Procedural Duration of the Nodule Localization | 7.4 min | Standard Deviation 3.2 |
Secondary
Radiation Dose
Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.
Time frame: From the time of completing final CT scan, assessed up to 1 hour.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-guided Localization | Radiation Dose | 313 mGy*cm | Standard Deviation 84 |
| Template-guided Localization | Radiation Dose | 229 mGy*cm | Standard Deviation 65 |