Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
NCT ID: NCT04937283
Last Updated: 2024-06-17
Study Results
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Basic Information
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RECRUITING
NA
690 participants
INTERVENTIONAL
2019-10-01
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Segmentectomy 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 after a comprehensive evaluation. As with lobectomy, 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 in the same manner as with lobectomy. When lymph node metastasis is present or resection margin is not cancer-free, the surgical procedure must be converted to a lobectomy.
Segmentectomy 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.
Lobectomy with systemic lymph node dissection
lobectomy 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 intraoperatively. 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.
Lobectomy with hilar and mediastinal 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.
Interventions
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Segmentectomy 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.
Lobectomy with hilar and mediastinal 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.
Eligibility Criteria
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Inclusion Criteria
* Tumor size \<= 2cm on preoperative CT scan;
* Peripheral solitary nodule or the associated lesion is MIA or less invasive lesion;
* Preoperative CT indicated that the nodules were non-pure glass nodules (consolidation to tumor ratio \>= 0.25);
* Intraoperative frozen section confirmed invasive lung adenocarcinoma with micropapillary and solid subtype negative (\<= 5%);
* Intraoperative frozen section indicated the resection margins was free of tumor cells;
* Lung function could withstand both lung segmentectomy and lobectomy (FEV1 \> 1.5L or FEV1% \>= 60%);
* Eastern Cooperative Oncology Group, 0 to 2;
* Volunteer to participate the trial and sign the informed consent, able to comply with the follow-up plan and other program requirements.
Exclusion Criteria
* The nodule is close to the lung hilus and is unable to perform segmentectomy;
* Intraoperative frozen section confirmed with micropapillary and solid subtype positive (\> 5%);
* Intraoperative frozen section confirmed adenocarcinoma in situ and minimally invasive adenocarcinoma;
* Preoperative imaging examination or EBUS indicated lymph node positive metastasis;
* Preoperative imaging examination revealed distant metastasis;
* Patients with severe damage to heart, liver and kidney function (grade 3 \~ 4, ALT and/or AST over 3 times the normal upper limit, Cr over the normal upper limit);
* Patients with other malignant tumors;
* Pregnant, planned pregnancy and lactating female patients (urine HCG\>2500IU/L is diagnosed as early pregnancy);
* Prior chemotherapy, radiation therapy or any other therapies were performed; 12 participated in other tumors within three months of relevant clinical subjects;
* Those who have participated in other tumor-related clinical trials within three months;
* Those are not suitable for participating in trials according to investigator's assessment.
20 Years
79 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Deping Zhao
Director of Thoracic Surgery, Shanghai Pulmonary Hospital
Principal Investigators
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Chang Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ning Xu
Role: primary
Mingran Xie
Role: primary
Xinwei Dong
Role: primary
Xuedong Zhang
Role: primary
Honggang Ke
Role: primary
Hao Xu
Role: primary
Jian Sun
Role: primary
Feng Jin
Role: primary
Xiaoyong Shen
Role: primary
Junqiang Fan
Role: primary
Qibin Shen
Role: primary
Xinjian Li
Role: primary
Guofang Zhao
Role: primary
Other Identifiers
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STAR001
Identifier Type: -
Identifier Source: org_study_id
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