Application of Three-Dimensionally Printed Navigational Template in Percutaneous Transthoracic Lung Biopsy: A Prospective, Randomized, Controlled, Noninferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Neoplasms
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Diagnostic yield of percutaneous transthoracic fine-needle aspiration
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Chang Chen
Prof. Dr.
Shanghai Pulmonary Hospital, Shanghai, China
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Diagnostic yield of percutaneous transthoracic fine-needle aspiration
Time Frame: Three to four working days post-biopsy were needed to establish the diagnosis of the cytological specimens acquired by 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.
Secondary Outcomes
- Radiation exposure(15 mins post biopsy)
- Diagnostic sensitivity of percutaneous transthoracic fine-needle aspiration(If an eventual diagnosis was attained by means of follow-up, a 12-month assessment was needed.)
- Complication rate(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.)
- Procedural duration(15 mins post biopsy)