Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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

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).

CT-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).

Template-guided lung biopsy

Haoran E, MD

Chang Chen, MD, PhD

Chang Chen, MD,PhD

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.

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

A percutaneous transthoracic fine-needle aspiration procedure was considered diagnostic if a malignant or specific benign diagnosis of the lesion was made. The ratio of diagnostic cases to all the participants who received the corresponding biopsy was considered as diagnostic yield.

All biopsy results that showed lung cancer were considered true positives (TP). For participants who had a nondiagnostic (intermediate or indeterminate) result from the first lung biopsy (fine-needle aspiration), subsequent diagnostic modalities including a re-biopsy, transbronchial needle aspiration or a 12-month follow-up was conducted to determine the final diagnosis. If any of these modalities demonstrated malignant, the case was considered a false negative (FN). Diagnostic sensitivity of the fine-needle aspiration procedure for lung cancer was defined as TP / (TP + FN).

The length of procedural duration was measured from the time a patient lain on the examining bed of the CT scanner to the time the first CT scan post fine-needle biopsy was conducted.

The dosage of the radiation exposure the participant received during the process of fine-needle aspiration.

Complication post fine-needle aspiration was evaluated by the first CT scan images post biopsy. Common complications include pneumothorax, pulmonary hemorrhage and hemoptysis. Complications needed further interventions were specially recorded.

Shanghai Pulmonary Hospital, Shanghai, China

Prof. Dr.

Multiple Pulmonary Nodules

Participants receive transthoracic lung biopsy guided by navigational template.

The navigational template was created based on computed tomography data using three-dimensional technology.

navigational template

Chang Chen, MD,Ph.D

This study evaluates the feasibility of three-dimensional printed template in transthoracic pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy schedule to receive template-guided transthoracic needle aspiration.

In previous study,a navigational template has been created to simplify the procedure of preoperative lung nodule localization. It was reported that localizer deviation was 10(0-20)mm.In this trial,Investigator explores the utility of this navigational template in transthoracic lung nodule biopsy.

Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial

Transthoracic Needle Biopsy for the Diagnosis of Pulmonary Nodule Using Three-dimensional Printed Navigational Template: A Phase I Feasibility Trial

Clinician evaluate the relative position between biopsy needle and the target lesion on CT images after needle insertion.

The length of procedural time is measured from the time a patient is lying on the examining bed of the CT scanner to the time he/she complete the biopsy procedure and step off the CT table.

How much radiation exposure patients would receive in the whole process of transthoracic needle biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy	NCT04775901	Lung Neoplasms	CT-guided lung ... Template-guided...	18 Years - 80 Years	Shanghai Pulmonary Hospital, Shanghai, China
Transthoracic Needle Biopsy Using 3D Printed Navigational Template: A Phase I Feasibility Trial	NCT03325907	Lung Neoplasms	navigational te...	18 Years - 80 Years	Shanghai Pulmonary Hospital, Shanghai, China
Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy	NCT04775901	Lung Neoplasms	CT-guided lung ... Template-guided...	18 Years - 80 Years	Shanghai Pulmonary Hospital, Shanghai, China
Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy	NCT04775901	Lung Neoplasms	CT-guided lung ... Template-guided...	18 Years - 80 Years	Shanghai Pulmonary Hospital, Shanghai, China

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