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

NCT07005401 | Completed

• 1 other identifier: TSCI 002
• Study Type: observational
• Target: 1,064
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-small cell lung cancer; Segmentectomy; Wedge resection; Margin quality

Outcome Measures

Primary Outcomes (1)

• surgical margin quality

  A surgical margin ≥ the maximum tumor diameter was considered sufficient.

  Perioperative

Study Arms (2)

Patients undergoing eligible sublobar resection

A surgical margin ≥ the maximum tumor diameter was considered sufficient. Sublobar resection with a sufficient surgical margin was considered eligible.

Patients undergoing lobectomy or ineligible sublobar resection

Patients who underwent lobectomy or received ineligible sublobar resection (sublobar resection with an insufficient surgical margin: less than the maximum tumor diameter)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with small-sized pulmonary nodules who underwent lobectomy or sublobar resection between 2020 and 2023 in a single surgical team were retrospectively screened.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Liang Chen, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: January 1, 2020
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)