Status:
UNKNOWN
Systematic Sampling of Lymph Nodes vs. Lymphadenectomy According to Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma With Ground-glass Opacity
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Collaborating Sponsors:
Changhai Hospital
Shanghai 10th People's Hospital
Conditions:
Lymph Node Excision
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the impact of systematic sampling of lymph nodes vs. lymphadenectomy on outcome according to intraoperative frozen pathology for pulmonary invasive adenocarcin...
Detailed Description
On HRCT screening, early lung adenocarcinoma often contains a nonsolid component called ground-glass opacity (GGO). In 2011, pulmonary adenocarcinomas were classified into atypical adenomatous hyperpl...
Eligibility Criteria
Inclusion
- A peripheral nodular lesion;
- The maximum diameters of whole GGO lesions and solid components on lung windows were no more than 3 cm (T1 stage);
- VATS lobectomy
- 25%≦Consolidation/Tumor ratio ≦50%
- ECOG performance status 0-2;
- Without distant metastasis;
- Intraoperative frozen pathology confirmed invasive or minimally invasive adenocarcinoma.
- No operation contraindication
- Cardiovascular: Cardiac function normal
- Renal: Creatinine clearance greater than 60 ml/min
- The expected survival after surgery ≥ 6 months
- Must be able to sign written informed consent form
Exclusion
- Age less than 18 years old
- Known hereditary bleeding disorder with history of post-operative hemorrhage
- Patients maintained on chronic anticoagulation (eg Coumadin therapy)
- Known hematogenous disorder
- Known primary or secondary malignancy
- Pregnant or breast-feeding women;
- Clinically significant heart disease;
- Patients who are unwilling or unable to comply with study procedures;
- Receiving immunosuppressive therapy;
- HIV/AIDS.
- Multiple lesions in lung
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2023
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03322826
Start Date
December 8 2017
End Date
October 28 2023
Last Update
December 19 2017
Active Locations (1)
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1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200000