Back to resultsApplication of 3D Printing Technique in Small Pulmonary Nodule Localization
Primary Purpose
Lung Neoplasm, Thoracic Surgery, Video-Assisted
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
template-guided localization
CT-guided localization
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasm focused on measuring Printing, Three-dimensional
Eligibility Criteria
Inclusion Criteria:
- Aged from 19 to 80 years
- lesions located in peripheral lung tissue which can be removed by wedge resection
- The maximum diameter of the lesion is no more than 20 mm.
- Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization
- Informed consent was signed voluntarily.
Exclusion Criteria:
- nodule located in the scapula region.
- there were two or more lung nodules needed to be localized.
Sites / Locations
- Shanghai Pulmonary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
CT-guided localization
template-guided localization
Arm Description
This group of participants received conventional CT-guided lung nodule localization.
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
Outcomes
Primary Outcome Measures
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.)
Secondary Outcome Measures
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.
Radiation Dose
Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.
Complication Rate
Pnuemothorax related to lung nodule localization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02952261
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2016 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chang Chen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm, Thoracic Surgery, Video-Assisted
Keywords
Printing, Three-dimensional
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-guided localization
Arm Type
Other
Arm Description
This group of participants received conventional CT-guided lung nodule localization.
Arm Title
template-guided localization
Arm Type
Experimental
Arm Description
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
Intervention Type
Device
Intervention Name(s)
template-guided localization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CT-guided localization
Intervention Description
Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
Primary Outcome Measure Information:
Title
Accuracy of Lung Nodule Localization
Description
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.
Secondary Outcome Measure Information:
Title
Procedural Duration of the Nodule Localization
Description
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.
Title
Radiation Dose
Description
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.
Title
Complication Rate
Description
Pnuemothorax related to lung nodule localization
Time Frame
From the time of completing final CT scan, assessed up to 2 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged from 19 to 80 years
lesions located in peripheral lung tissue which can be removed by wedge resection
The maximum diameter of the lesion is no more than 20 mm.
Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization
Informed consent was signed voluntarily.
Exclusion Criteria:
nodule located in the scapula region.
there were two or more lung nodules needed to be localized.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Chen, MD,Ph.D
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29017792
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.
Results Reference
background
PubMed Identifier
30586136
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.
Results Reference
derived
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Application of 3D Printing Technique in Small Pulmonary Nodule Localization
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