Non Small Cell Lung Cancer Clinical Trial
Official title:
Preoperative Lymph Node Staging by EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer
The introduction of modern staging systems has increased the detection of small peripheral lung cancers at an early stage [1]. Stage I non-small-cell lung cancers (NSCLCs) are confined to the lung without lymph node involvement, and surgical resection is currently considered the standard therapeutic approach. Nodal staging is initially performed non-invasively with computer tomography (CT) and positron emission tomography (PET) scans followed by minimally invasive staging with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) when CT and/or PET are suggestive of mediastinal nodal involvement. Lobectomy with radical lymphadenectomy is currently considered the treatment of choice for early-stage lung cancer. Several studies demonstrated that primary invasive non- small-cell lung carcinomas > 2.0 cm were twice as likely to have nodal metastases as carcinomas ≤ 2.0 cm, emphasizing that small lung cancers had less lymph node involvement and confirming a better survival. In our pilot study [18] published in 2011 in the European Journal of Thoracic Surgery, no nodal involvement was observed in any of the 62 patients with pulmonary nodule size less than 10 mm, in 20 out of 120 patients (17%) with nodule size 11-20 mm, and in 9 out of 37 tumors (24%) 21-30 mm in size (p = 0.0007). These patients could be spared radical lymph node dissection if deemed not essential, thereby reducing operative risks, postoperative morbidity, and surgery time. A preoperative diagnostic determination to establish the size and correct staging of the tumor is mandatory for appropriate selection of candidates, avoiding unnecessary surgery.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 20, 2022 |
Est. primary completion date | September 29, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Suspected or proven non-small cell lung cancer (NSCLC) clinical stage I and II (diameter > 1 cm and less than 5 cm, no pleura invasion) clinical N0M0 (8th TNM) - All patients have to be staged by total body CT scan and PET-FDG - Negative preoperative staging at hilar and mediastinal level at CT and CT/PET (PET negative and lymph node short axis < 1 cm at CT scan) - Age between 18 and 75 years old Exclusion Criteria: - NSCLC smaller or equal than 1 cm - Unfit for bronchoscopy or surgical resection - Evidence of locally advanced or metastatic disease - Prior chemotherapy or radiotherapy for this malignancy - Other malignancy within the past 5 years except for not melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix - Previous surgical treatment for lung cancer - Multiple lung tumors |
Country | Name | City | State |
---|---|---|---|
Italy | European Institute of Oncology | Milan | Milano |
Lead Sponsor | Collaborator |
---|---|
European Institute of Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of the sensitivity of EBUS-TBNA in lymph node staging for early stage lung cancer | A sample size of 12 upstaged patients will achieve 80% power to detect a difference of sensitivity >38.4% assuming that the sensitivity under the null hypothesis is 49% (results of the meta-analysis by Leong et al, 2018 [22]), and that the actual sensitivity is >88% (95.6% in the study by Guarize et al, 2018 [25]) using a two-sided binomial test. | 17 months | |
Secondary | Assessment of concordance between EBUS-TBNA and surgery | Evaluation of diagnostic accuracy of both procedure in predicting the presence of lymph node metastasis | 17 months | |
Secondary | Assessment of lymph node upstaging by EBUS and surgery | Predictive false negative and pathological upstaging for both procedures | 17 months | |
Secondary | Assessment of the complication rates | Evaluation of the incidence of any type of complication in EBUS-TBNA procedures | 17 months |
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