Clinical trial · Interventional
Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy
Application of Three-Dimensionally Printed Navigational Template in Percutaneous Transthoracic Lung Biopsy: A Prospective, Randomized, Controlled, Noninferiority Trial
NCT04775901CI-TRIAL-00050383unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, randomized, controlled study to evaluate the diagnostic yield and safety of three-dimensionally printed navigational template in percutaneous transthoracic lung biopsy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-guided lung biopsy | Other | — | UNRESOLVED |
| Template-guided lung biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- CT-guided lung biopsy
- description
- Participants in this arm received conventional CT-guided percutaneous transthoracic lung biopsy.
- interventionNames
- Other: CT-guided lung biopsy
- type
- EXPERIMENTAL
- label
- Template-guided lung biopsy
- description
- 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.
- interventionNames
- Device: Template-guided lung biopsy
Primary outcomes (1)
- measure
- Diagnostic yield of percutaneous transthoracic fine-needle aspiration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Ⅰ. Inclusion Criteria: A. CT confirmed peripheral lung lesion; 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. Ⅱ. Exclusion Criteria: A. Biopsy needle insertion route impeded by skeletal structures; 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.
References
Publications (2)
- BACKGROUNDZhang 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. PMID 29017792
- BACKGROUNDZhang 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. PMID 30586136