Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy

Not Applicable

• Conditions: Lung Neoplasms
• Interventions: Device: Template-guided lung biopsy; Other: CT-guided lung biopsy

• Registration Number: NCT04775901
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Study Timeline

• Study Start: 2020-11-25
• Status Verified: 2021-02
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Template-guided lung biopsy	Template-guided 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.
CT-guided lung biopsy	CT-guided lung biopsy	Participants in this arm received conventional CT-guided percutaneous transthoracic lung biopsy.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of percutaneous transthoracic fine-needle aspiration	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 Outcome Measures

Name	Time	Method
Radiation exposure	15 mins post biopsy	The dosage of the radiation exposure the participant received during the process of fine-needle aspiration.
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.	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).
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.	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.
Procedural duration	15 mins post biopsy	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.

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China