Clinical trial NCT02952261: Application of 3D Printing Technique in Small Pulmonary Nodule Localization
Official title: Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm
Thoracic Surgery, Video-Assisted
Keywords: Printing, Three-dimensional
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of Lung Nodule Localization
timeFrame: From the time of completing final CT scan, assessed up to 2 days.
Secondary outcomes:
measure: Procedural Duration of the Nodule Localization
timeFrame: From the time of completing final CT scan, assessed up to 1 hour.
measure: Radiation Dose
timeFrame: From the time of completing final CT scan, assessed up to 1 hour.
measure: Complication Rate
timeFrame: From the time of completing final CT scan, assessed up to 2 days.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Chang Chen, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.