Diagnostic Efficiency Comparasion of Hand-Drawn Navigation and Virtual Navigation for Peripheral Pulmonary Nodules

NCT07053124 | Not Yet Recruiting DMC

• 1 other identifier: Hand-drawn navigation
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Peripheral pulmonary lesions (PPLs) refer to isolated or localized lesions located in the outer one-third of the lung field. Their qualitative diagnosis is a key link in the early screening and precise treatment of lung cancer. However, due to the deep location, small size (especially those with diameters \< 2 cm), and unclear relationship with bronchi of peripheral pulmonary lesions, traditional bronchoscopy is difficult to directly reach the lesion, resulting in a relatively low positive rate of biopsy. Moreover, although conventional imaging examinations (such as CT) can locate the lesions, they cannot provide a histological diagnostic basis. Percutaneous puncture under CT guidance has high risks such as pneumothorax, bleeding and pleural reaction, and has low efficiency in locating multiple lesions. At present, there are various auxiliary techniques for the diagnosis of peripheral pulmonary nodules, each with its own advantages and disadvantages:

1. 1.Image-guided techniques: Although traditional CT-guided percutaneous biopsy is intuitive in terms of localization, it has high complication risks and limited applicability for nodules close to the mediastinum or blood vessels.
2. 2.Radial Bronchial Endobronchial Ultrasound (RP-EBUS): Combined with a guide sheath (GS), it can increase the positive rate of peripheral nodule biopsy (the weighted diagnostic rate without fluoroscopy can reach 70%), but it relies on the operator's familiarity with bronchial anatomy and is difficult to solve complex bronchial path planning problems alone.
3. 3.Virtual Bronchoscopy Navigation (VBN): VBN generates virtual bronchial paths based on CT three-dimensional reconstruction, significantly shortening the operation time and improving the diagnostic rate (62.5%-84.4%, overall 73.8%). However, its limitations are obvious: it relies on high-quality CT images and is sensitive to respiratory motion artifacts; it cannot be adjusted in real time, and during the operation, it is prone to deviate from the navigation map due to anatomical variations or secretions, with high equipment costs and difficulty in popularization in grassroots hospitals.
4. 4.Electromagnetic Navigation Bronchoscopy (ENB): ENB achieves precise navigation through electromagnetic positioning, with a diagnostic rate of up to 70%-80%, but the equipment is expensive (single consumable cost is about 1-20,000 yuan), and it needs to be combined with intraoperative fluoroscopy.
5. 5.Robotic-assisted bronchoscopy navigation: Emerging technologies such as robotic-assisted navigation offer good stability and high precision in control, but they are complex in terms of technology and expensive in terms of equipment. Currently, they are only available in large medical centers in China.

Conditions

Peripheral Pulmonary Nodules

Keywords

Peripheral pulmonary nodules

Outcome Measures

Primary Outcomes (1)

• Intermediate Diagnosis yield

  Intermediate Diagnosis yield, which is calculated based on the follow-up data of cases where NSB was detected by bronchoscopy only. Only cases where subsequent biopsy or imaging examination confirmed non-malignant diagnosis (NSBTN) will be classified as true negatives; cases without a clear diagnosis due to lack of follow-up will be regarded as non-diagnosed. Patients who fail to navigate but switch paths to continue the biopsy to achieve a diagnosis will not be counted as successful cases. The calculation formula is (TP + SPB + NSBTN) divided by the total number of procedures. The differences between the two groups will be compared

  6 monthes after procedure

Study Arms (2)

Hand-drawn group

EXPERIMENTAL

Hand-drawn navigation was employed for diagnosing patients with PPN .

Other: Hand-drawn navigation

VBN group

ACTIVE COMPARATOR

Virtual bronchosocopy navigation was employed for diagnosing patients with PPN .

Other: Virtual bronchoscopy navigation

Interventions

Hand-drawn navigation OTHER

Hand-drawn navigation employed for diagnosing patients with PPN in Hand-drawn group.

Hand-drawn group

Virtual bronchoscopy navigation OTHER

Virtual bronchoscopy navigation employed for diagnosing patients with PPN in VBN group.

VBN group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years;
• Patients with pulmonary nodule and nodule size \>8mm but ≤ 30mm, bronchus level of the nodule ≥ grade 5, who are scheduled to undergo bronchoscopy biopsy for definitive diagnosis;
• In the judgment of investigator that the nodule is difficult to reach with conventional bronchoscopy and bronchoscopy guidance technology is needed.

You may not qualify if:

• Contraindications for bronchoscopy examination;
• Other situations what investigators consider inappropriate for participation.1.Contraindications for bronchoscopy examination; Other situations what investigators consider inappropriate for participation.

Sponsors & Collaborators

• Guangzhou Medical University: lead

Related Publications (1)

• Zhong CH, Su ZQ, Luo WZ, Rao WY, Feng JX, Tang CL, Chen Y, Chen XB, Fan MY, Li SY. Hierarchical clock-scale hand-drawn mapping as a simple method for bronchoscopic navigation in peripheral pulmonary nodule. Respir Res. 2022 Sep 14;23(1):245. doi: 10.1186/s12931-022-02160-0.

  PMID: 36104691 BACKGROUND

Central Study Contacts

Shiyue Li

CONTACT

02081566640; lishiyue@gird.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share