Factors Determine the Feasibility and Surgical Margin Quality of Sublobar Resection for Non-small Cell Lung Cancer?

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT07005401
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

Sublobar resection (SR) has been recognized as non-inferior to lobectomy for small-sized non-small cell lung cancer (NSCLC). This study aimed to systematically identify the potential factors influencing the feasibility and surgical margin quality of SR for small-sized NSCLC.

Patients with small-sized NSCLC (≤2 cm) who underwent SR or lobectomy between 2020 and 2023 were screened. Surgical procedures were determined by discussion under the guidance of 3D-CTBA. A surgical margin ≥ the maximum tumor diameter was considered sufficient. SR with a sufficient surgical margin was considered eligible. Univariate and multivariate logistic regression analyses were performed to identify factors affecting the feasibility and margin quality of SR.

Detailed Description

Patients with small-sized pulmonary nodules who underwent lobectomy or SR between 2020 and 2023 in a single surgical team were retrospectively screened. All the surgical approach was jointly determined by three experienced surgeons (at least 15 years, Doctor Liang Chen, Weibing Wu and Zhicheng He). Patients satisfied with the following criteria were initially reserved: (1) the maximum nodule diameter ≤ 2 cm; (2) single malignant nodule; (3) intentional resection; (4) histopathological confirmed primary NSCLC. Further, patients with (1) interlobar lesions; (2) nodules in the right middle lobe; (3) receiving neoadjuvant before surgery; (4) poor CT quality were excluded.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1064

Inclusion Criteria

• the maximum nodule diameter ≤ 2 cm
• single malignant nodule
• intentional resection
• histopathological confirmed primary non-small cell lung cancer

Exclusion Criteria

• interlobar lesions
• nodules located in the right middle lobe
• receiving neoadjuvant before surgery
• poor CT quality were excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
surgical margin quality	Perioperative	A surgical margin ≥ the maximum tumor diameter was considered sufficient.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China