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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-guided localization | Other | This group of participants received conventional CT-guided lung nodule localization. |
|
| template-guided localization | Experimental | Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| template-guided localization | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | From the time of completing final CT scan, assessed up to 2 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the time of completing final CT scan, assessed up to 1 hour. |
| Radiation Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang Chen, MD,Ph.D | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29017792 | Background | Zhang L, Li M, Li Z, Kedeer X, Wang L, Fan Z, Chen C. Three-dimensional printing of navigational template in localization of pulmonary nodule: A pilot study. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2113-2119.e7. doi: 10.1016/j.jtcvs.2017.08.065. Epub 2017 Sep 1. | |
| 30586136 | Derived | Zhang L, Wang L, Kadeer X, Zeyao L, Sun X, Sun W, She Y, Xie D, Li M, Zou L, Rocco G, Yang P, Chen C, Liu CC, Petersen RH, Ng CSH, Parrish S, Zhang YS, Giordano R, di Tommaso L; AME Thoracic Surgery Collaborative Group. Accuracy of a 3-Dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules: A Noninferiority Randomized Clinical Trial. JAMA Surg. 2019 Apr 1;154(4):295-303. doi: 10.1001/jamasurg.2018.4872. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.) | Modified Intention-to-treat analysis (patients who did not receive lung nodule localization were excluded.(n=10)) | Posted | Mean | Standard Deviation | mm | From the time of completing final CT scan, assessed up to 2 days. |
|
Adverse event were assessed immediately after lung nodule localization through CT scanning, assessed up to 2 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pnueumothorax | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chang Chen | Shanghai Pulmonary Hospital affiliated to Tongji university | +86 13816869003 | chenthoracic@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2016 | Feb 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| CT-guided localization | Other | Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization. |
|
Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage. |
| From the time of completing final CT scan, assessed up to 1 hour. |
| Complication Rate | Pnuemothorax related to lung nodule localization | From the time of completing final CT scan, assessed up to 2 days. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| BMI(body mass index) | Mean | Standard Deviation | Kg/m^2 |
|
| FEV1（of percentage predicted） | Mean | Standard Deviation | Percentage predicted FEV1 |
|
| Nodule size | nodule size measured by long-axis diameter | Mean | Standard Deviation | mm |
|
| Nodule location | Count of Participants | Participants |
|
| Nodule type | Count of Participants | Participants |
|
| Distance from pleura | Median | Full Range | mm |
|
| OG001 |
| 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | min | From the time of completing final CT scan, assessed up to 1 hour. |
|
|
|
| Secondary | Radiation Dose | Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage. | Posted | Mean | Standard Deviation | mGy*cm | From the time of completing final CT scan, assessed up to 1 hour. |
|
|
|
| Secondary | Complication Rate | Pnuemothorax related to lung nodule localization | Posted | Count of Participants | Participants | From the time of completing final CT scan, assessed up to 2 days. |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 28 |
| 95 |
| EG001 | 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. | 0 | 95 | 0 | 95 | 16 | 95 |
| Hemorrhage | Surgical and medical procedures | Non-systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |