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

  • STATUS
    Recruiting
  • End date
    Oct 28, 2023
  • participants needed
    600
  • sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
Updated on 31 January 2022

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.

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.

Details
Condition Lymph Node Excision
Treatment Lymphadenectomy, systematic sampling of the lymph-node
Clinical Study IdentifierNCT03322826
SponsorShanghai Pulmonary Hospital, Shanghai, China
Last Modified on31 January 2022

Eligibility

Yes No Not Sure

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
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