Status:
UNKNOWN
Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
NA
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-inferiori...
Eligibility Criteria
Inclusion
- Ⅰ.
- 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
- 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.
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04775901
Start Date
November 25 2020
End Date
December 31 2023
Last Update
March 1 2021
Active Locations (1)
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1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433