Early-Stage Lung Cancer, Pulmonary Nodules
Conditions
Brief summary
Pulmonary nodules, particularly small and non-palpable nodules, present challenges for accurate localization during sublobar lung resection. This multicenter observational cohort study evaluated the feasibility, accuracy, and safety of CT-Free electromagnetic navigation percutaneous localization for pulmonary nodules requiring sublobar resection. Patients who underwent CT-Free electromagnetic navigation localization were compared with patients who received conventional CT-guided localization. The primary outcome was localization success rate, defined as the distance between the localization marker and the pulmonary nodule center being within 10 mm. Secondary outcomes included localization procedure time, conversion rate to other localization methods, surgical success rate, perioperative complications, postoperative hospitalization duration, and medical resource utilization.
Interventions
None listed
Sponsors
Jianle Chen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older. 2. Patients with pulmonary nodules requiring sublobar resection. 3. Non-palpable pulmonary nodules requiring preoperative localization. 4. Patients undergoing CT-Free electromagnetic navigation localization or CT-guided localization.
Exclusion criteria
1. Central pulmonary nodules unsuitable for localization. 2. Patients unable to undergo sublobar resection. 3. Patients with severe cardiopulmonary dysfunction or major organ dysfunction. 4. Pregnancy or breastfeeding. 5. Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm | Immediately after surgical resection | The proportion of participants with successful pulmonary nodule localization, defined as a distance between the localization marker and the pulmonary nodule center of ≤10 mm, measured by postoperative pathological specimen evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Requiring Additional Localization Procedures | During surgery | The proportion of participants requiring additional localization methods because of unsuccessful or inaccurate initial localization. |
| Number of Participants With Procedure-Related Complications | Within 30 days after surgery | Procedure-related complications including pneumothorax, pulmonary hemorrhage, and infection occurring after localization and surgery. |
| Duration of Pulmonary Nodule Localization Procedure | From initiation to completion of the localization procedure | The duration from initiation of localization preparation to completion of marker placement. |
| Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm) | Immediately after surgical specimen resection | The mean distance between the localization marker and the pulmonary nodule center measured immediately after surgical specimen resection. |
| Mean Duration of Postoperative Hospital Stay | Up to 30 days after surgical resection | The mean duration of hospitalization after surgical resection, calculated from the date of surgery to the date of hospital discharge. |
Countries
China
Outcome results
None listed