CT-Free Electromagnetic Navigation Percutaneous Localization for Pulmonary Nodules Undergoing Sublobar Resection

Jianle Chen153 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

153

Conditions

Pulmonary Nodules Early-Stage Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm

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.

Time frame: Immediately after surgical resection

Secondary Outcomes

Proportion of Participants Requiring Additional Localization Procedures

The proportion of participants requiring additional localization methods because of unsuccessful or inaccurate initial localization.

Time frame: During surgery

Number of Participants With Procedure-Related Complications

Procedure-related complications including pneumothorax, pulmonary hemorrhage, and infection occurring after localization and surgery.

Time frame: Within 30 days after surgery

Duration of Pulmonary Nodule Localization Procedure

The duration from initiation of localization preparation to completion of marker placement.

Time frame: From initiation to completion of the localization procedure

Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm)

The mean distance between the localization marker and the pulmonary nodule center measured immediately after surgical specimen resection.

Time frame: Immediately after surgical specimen resection

Mean Duration of Postoperative Hospital Stay

The mean duration of hospitalization after surgical resection, calculated from the date of surgery to the date of hospital discharge.

Time frame: Up to 30 days after surgical resection