Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy
NCT ID: NCT04775901
Last Updated: 2021-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-11-25
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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CT-guided lung biopsy
Participants in this arm received conventional CT-guided percutaneous transthoracic lung biopsy.
CT-guided lung biopsy
Percutaneous transthoracic lung biopsy was conducted stepwise under the real-time guidance of CT scan. This kind of modality served as an effective method for diagnosing peripheral lung lesions (all of the participants received fine-needle aspiration, some of them received coaxial needle biopsy as well, according to the pulmonologist's instruction).
Template-guided lung biopsy
Three-dimensionally printed navigational template was designed based on the CT scan images acquired before the biopsy. Under the guidance of navigational template, percutaneous transthoracic lung biopsy was conducted.
Template-guided lung biopsy
A three-dimensional model consisting of participant's thoracic image information was initially reconstructed based on the CT scan data. Afterwards, a navigational template was customized, which accommodated well to the anatomical landmarks of the participant. The template was then printed by means of stereolithography from photopolymer material. Participants would receive navigational template-guided percutaneous transthoracic lung biopsy (all of the participants received fine-needle aspiration, some of them received coaxial needle biopsy as well, according to the pulmonologist's instruction).
Interventions
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CT-guided lung biopsy
Percutaneous transthoracic lung biopsy was conducted stepwise under the real-time guidance of CT scan. This kind of modality served as an effective method for diagnosing peripheral lung lesions (all of the participants received fine-needle aspiration, some of them received coaxial needle biopsy as well, according to the pulmonologist's instruction).
Template-guided lung biopsy
A three-dimensional model consisting of participant's thoracic image information was initially reconstructed based on the CT scan data. Afterwards, a navigational template was customized, which accommodated well to the anatomical landmarks of the participant. The template was then printed by means of stereolithography from photopolymer material. Participants would receive navigational template-guided percutaneous transthoracic lung biopsy (all of the participants received fine-needle aspiration, some of them received coaxial needle biopsy as well, according to the pulmonologist's instruction).
Eligibility Criteria
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Inclusion Criteria
B. Nodule size larger than or equal to 30 mm;
C. Scheduled for percutaneous transthoracic fine-needle aspiration;
D. Percutaneous transthoracic lung biopsy was conducted at supine or partially lateral decubitus;
E. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
F. Written informed consent provided.
Exclusion Criteria
B. Lesion within 3 cm above diaphragmatic dome;
C. Insertion route longer than the biopsy needle;
D. Lung biopsy needed to be conducted at vertically lateral decubitus;
E. Any contraindication of percutaneous transthoracic lung biopsy;
F. Women who are pregnant or in the period of breastfeeding.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Chang Chen
Prof. Dr.
Principal Investigators
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Chang Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Tongji University School of Medicine
Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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L20-241
Identifier Type: -
Identifier Source: org_study_id
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