A Prospective and Multi-center RCT Study of Lymphadenectomy Based on Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma Presenting With Ground Glass Opacity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- recurrence-free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
- •Multiple lesions in lung
研究组 & 干预措施
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
干预措施: lymphadenectomy (Procedure)
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
干预措施: systematic sampling of the lymph-node (Procedure)
结局指标
主要结局
recurrence-free survival
时间窗: five years after surgery
recurrence-free survival status of patients after surgery
次要结局
- Overall Survival(five years after surgery)
- Mortality rate(up to 30 days after surgery)
- Morbidity rate(up to 30 days after surgery)
研究者
Chang Chen
Vice President
Shanghai Pulmonary Hospital, Shanghai, China