Systematic Sampling of Lymph Nodes vs. Lymphadenectomy According to Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma With Ground-glass Opacity
NCT ID: NCT03322826
Last Updated: 2017-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2017-12-08
2023-10-28
Brief Summary
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Detailed Description
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Nowadays, intraoperative frozen pathology is widely used during operation. However, whether sampling of lymph nodes or lymphadenectomy should be performed for GGO lesions according to intraoperative pathological diagnosis is unclear. The aim of this prospective study is to evaluate whether there are any trends regarding the impact of subtypes of invasive adenocarcinoma according to intraoperative frozen pathology in sampling of lymph nodes vs. lymphadenectomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lymphadenectomy
systematically Lymphadenectomy of the lymph-node stations ATS 2, 4, 7, 8, 9,10,11 on the right side and ATS 5, 6, 7, 8, 9,10,11 on the left side
lymphadenectomy
Routine lymph nodes dissection in lung cancer
systematic sampling of the lymph nodes
systematic sampling of the lymph-node stations ATS 2, 4, 7, 8, 9,10,11 on the right side and ATS 5, 6, 7, 8, 9,10,11 on the left side
systematic sampling of the lymph-node
Systematic Sampling of lymph nodes
Interventions
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systematic sampling of the lymph-node
Systematic Sampling of lymph nodes
lymphadenectomy
Routine lymph nodes dissection in lung cancer
Eligibility Criteria
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Inclusion Criteria
2. The maximum diameters of whole GGO lesions and solid components on lung windows were no more than 3 cm (T1 stage);
3. VATS lobectomy
4. 25%≦Consolidation/Tumor ratio ≦50%
5. ECOG performance status 0-2;
6. Without distant metastasis;
7. Intraoperative frozen pathology confirmed invasive or minimally invasive adenocarcinoma.
8. No operation contraindication
9. Cardiovascular: Cardiac function normal
10. Renal: Creatinine clearance greater than 60 ml/min
11. The expected survival after surgery ≥ 6 months
12. Must be able to sign written informed consent form
Exclusion Criteria
2. Known hereditary bleeding disorder with history of post-operative hemorrhage
3. Patients maintained on chronic anticoagulation (eg Coumadin therapy)
4. Known hematogenous disorder
5. Known primary or secondary malignancy
6. Pregnant or breast-feeding women;
7. Clinically significant heart disease;
8. Patients who are unwilling or unable to comply with study procedures;
9. Receiving immunosuppressive therapy;
10. HIV/AIDS.
11. Multiple lesions in lung
18 Years
80 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Shanghai 10th People's Hospital
OTHER
Ruijin Hospital
OTHER
RenJi Hospital
OTHER
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Chang Chen
Vice President
Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Chang Chen, MD,PhD
Role: primary
References
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Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094.
Ye B, Cheng M, Li W, Ge XX, Geng JF, Feng J, Yang Y, Hu DZ. Predictive factors for lymph node metastasis in clinical stage IA lung adenocarcinoma. Ann Thorac Surg. 2014 Jul;98(1):217-23. doi: 10.1016/j.athoracsur.2014.03.005. Epub 2014 May 17.
Other Identifiers
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SHDC12015116
Identifier Type: -
Identifier Source: org_study_id