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

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.

The feasibility of three-dimensionally printed navigational template-guided percutaneous transthoracic fine-needle aspiration was validated by a phase I study. To further investigate the non-inferiority of navigational template-guided lung biopsy to conventional CT-guided modality in terms of diagnostic yield, this prospective, randomized, controlled, noninferiority trial was conducted.

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.