Clinical trial · Interventional
Preoperative Lymph Node Staging With EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer
Preoperative Lymph Node Staging by EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endobronchial ultrasound transbronchial needle aspiration lymph node staging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EBUS-TBNA procedure
- description
- Single arm protocol. Invasive mediastinal staging with EBUS-TBNA in clinical N0 NSCLC patients candidate to surgical resection with systematic lymphadenectomy.
- interventionNames
- Procedure: Endobronchial ultrasound transbronchial needle aspiration lymph node staging
Primary outcomes (1)
- measure
- Assessment of the sensitivity of EBUS-TBNA in lymph node staging for early stage lung cancer
- timeFrame
- 17 months
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available