RecruitingNot ApplicableNCT04937283

Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Negative by Intraoperative Frozen Sections: A Prospective and Multi-center Randomized Controlled Trial Study


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

690 participants

Start Date

Oct 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative 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 — segmentectomy (removing just the segment of lung containing the tumor) versus lobectomy (removing the entire lobe of the lung) — for people with small early-stage lung adenocarcinoma (a type of lung cancer) of 2 cm or less. **You may be eligible if...** - You are between 20 and 79 years old - Your lung tumor is 2 cm or smaller on a CT scan - The tumor is in the outer part of the lung and shows signs of invasion (not pure ground-glass appearance) - Your lung function is good enough to tolerate either type of surgery - The tumor is confirmed as invasive lung adenocarcinoma by intraoperative frozen biopsy **You may NOT be eligible if...** - Your tumor is larger than 2 cm - Your tumor has specific high-risk subtypes (micropapillary or solid pattern >5%) - Your lung function is too poor for surgery - Your cancer has spread to lymph nodes or other parts of the body 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

PROCEDURESegmentectomy

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.

PROCEDURELobectomy

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.


Locations(14)

Anhui Chest Hospital

Hefei, Anhui, China

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Nanyang Central Hospital

Nanyang, Henan, China

The Sixth People's Hospital of Nantong

Nantong, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Yancheng First People's Hospital

Yancheng, Jiangsu, China

Shandong Public Health Clinical Center

Jinan, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Huadong Hospital

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Huzhou Central Hospital

Huzhou, Zhejiang, China

Ningbo First Hospital

Ningbo, Zhejiang, China

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

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NCT04937283


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