RecruitingNCT05838053

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Positive by Frozen Section: A Prospective, Observational, Multicenter Cohort Study

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

446 participants

Start Date

Aug 20, 2019

Study Type

OBSERVATIONAL

Conditions

Lung Adenocarcinoma

Summary

This study aims to evaluate the superiority in recurrence-free survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype positive by intraoperative frozen sections.

Eligibility

Min Age: 20 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study compares two types of lung surgery — removing a small segment of lung (segmentectomy) versus removing an entire lobe (lobectomy) — for people with small lung cancer tumors 2 cm or smaller. Researchers want to know if the smaller surgery is just as effective while preserving more lung function. **You may be eligible if...** - You have a small (2 cm or less), single lung tumor located in the outer part of the lung - Biopsy confirms invasive lung adenocarcinoma with specific aggressive features (micropapillary or solid pattern) - Your lungs are healthy enough to tolerate either type of surgery - Imaging shows the tumor is confined and has not spread **You may NOT be eligible if...** - Your tumor is larger than 2 cm or located centrally in the lung - You have multiple tumors suggesting more advanced disease - Your lung function is too poor to safely undergo surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELobectomy with systemic lymph node dissection

Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.

PROCEDURESegmentectomy with systemic lymph node dissection

Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.