Systematic Sampling of Lymph Nodes vs. Lymphadenectomy According to Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma With Ground-glass Opacity

Study Overview
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Brief Summary
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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 adenocarcinoma with ground-glass opacity (GGO) after VATS lobectomy.

Detailed Description
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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 hyperplasia (AAH), adenocarcinoma in situ (AIS), minimally invasive carcinoma (MIA) and more extensively invasive adenocarcinoma (IAC) [1]. Early adenocarcinomas with GGO-dominant always mean low-grade malignancy and have an extremely favorable prognosis [2-5]. Previous studies have shown that patients with AAH, AIS and MIA have excellent survival rates (5-year survival rate is approximate 95%) after resection, and only 0.83% - 2.91% patients have lymph node metastasis [6-9]. At present, lymphadenectomy is always undergone in patients with pulmonary adenocarcinoma with ground-glass opacity. However, for MIA patients (especially in T1a-b stage), the appropriate use of lymphadenectomy continues to be debated. 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.

Official Title
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A Prospective and Multi-center RCT Study of Lymphadenectomy Based on Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma Presenting With Ground Glass Opacity

Conditions
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Lymph Node Excision

Intervention / Treatment
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* Procedure: systematic sampling of the lymph-node
* Procedure: lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lymphadenectomy<br>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 | Procedure: lymphadenectomy<br>* Routine lymph nodes dissection in lung cancer<br>|
| Experimental: systematic sampling of the lymph nodes<br>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 | Procedure: systematic sampling of the lymph-node<br>* Systematic Sampling of lymph nodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence-free survival | recurrence-free survival status of patients after surgery | five years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | survival status of patients after surgery | five years after surgery | 
| Morbidity rate | the rates of complications related to treatment during perioperative period | up to 30 days after surgery | 
| Mortality rate | the rates of death related to treatment during perioperative period | up to 30 days after surgery |