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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
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).
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).
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDiagnostic yield of percutaneous transthoracic fine-needle aspiration
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.
Time frame: Three to four working days post-biopsy were needed to establish the diagnosis of the cytological specimens acquired by fine-needle aspiration.
Diagnostic sensitivity of percutaneous transthoracic fine-needle aspiration
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).
Time frame: If an eventual diagnosis was attained by means of follow-up, a 12-month assessment was needed.
Procedural duration
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.
Time frame: 15 mins post biopsy
Radiation exposure
The dosage of the radiation exposure the participant received during the process of fine-needle aspiration.
Time frame: 15 mins post biopsy
Complication rate
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.
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Time frame: Real-time complication post biopsy indicates those recognized by the immediate CT scan, while delayed complication indicates those recognized by radiograph taken 4-6 hours post biopsy.