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This study evaluates the feasibility of three-dimensional printed template in transthoracic pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy schedule to receive template-guided transthoracic needle aspiration.
In previous study,a navigational template has been created to simplify the procedure of preoperative lung nodule localization. It was reported that localizer deviation was 10(0-20)mm.In this trial,Investigator explores the utility of this navigational template in transthoracic lung nodule biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| template-guided biopsy | Experimental | Participants receive transthoracic lung biopsy guided by navigational template. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| navigational template | Device | The navigational template was created based on computed tomography data using three-dimensional technology. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of needle insertion | Clinician evaluate the relative position between biopsy needle and the target lesion on CT images after needle insertion. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| procedural length | The length of procedural time is measured from the time a patient is lying on the examining bed of the CT scanner to the time he/she complete the biopsy procedure and step off the CT table. | 1 hour |
| radiation dosage |
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Inclusion Criteria:
CT confirmed peripheral lung nodule; Nodule size larger than or equal to 3 cm; ECOG Performance Status 0-2 ; Informed consent.
Exclusion Criteria:
Nodule located in the scapula region wherein biopsy needle is impeded; Nodule within 3 cm above diaphragmatic dome.
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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 | Result | 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. | |
| 35399565 | Derived | E H, Chen J, Sun W, Zhang Y, Ren S, Shi J, Wen Y, Su C, Ni J, Zhang L, He Y, Chen B, Casal RF, Kheir F, Ishiwata T, Zhang J, Zhao D, Chen C. Three-dimensionally printed navigational template: a promising guiding approach for lung biopsy. Transl Lung Cancer Res. 2022 Mar;11(3):393-403. doi: 10.21037/tlcr-22-172. |
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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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single-armed feasibility trial
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How much radiation exposure patients would receive in the whole process of transthoracic needle biopsy.
| 1 hour |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |