Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy

Shanghai Pulmonary Hospital, Shanghai, China

Status: Unknown

Conditions: Lung Neoplasms

Treatments: Device: Template-guided lung biopsy; Other: CT-guided lung biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04775901

L20-241

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

CT-guided lung biopsy

Other group

Description:

Participants in this arm received conventional CT-guided percutaneous transthoracic lung biopsy.

Treatment:

Other: CT-guided lung biopsy

Template-guided lung biopsy

Experimental group

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.

Treatment:

Device: Template-guided lung biopsy