NCT03322826

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 adenocarcinoma with ground-glass opacity (GGO) after VATS lobectomy.

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 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.

Conditions

• Lymph Node Excision

Interventions

Type	Name	Description
PROCEDURE	systematic sampling of the lymph-node	Systematic Sampling of lymph nodes
PROCEDURE	lymphadenectomy	Routine lymph nodes dissection in lung cancer

Timeline

• Start date: 2017-12-08
• Primary completion: 2021-10-28
• Completion: 2023-10-28
• First posted: 2017-10-26
• Last updated: 2017-12-19

Locations

1 site across 1 country: China