EBUS-TBNA for Lung Cancer
Palo Alto (17 mi)Overseen byKazuhiro Yasufuku, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University Health Network, Toronto
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?It is reported that more than 90,000 patients died of lung cancer and more than 20% of them were older than 80 years in North America. Therefore a less invasive but effective treatment is required for patients with lung cancer of advanced age, diminished pulmonary functions, and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the other hand, accurate mediastinal and hilar lymph node staging is one of the most important factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung cancer to undergo minimally invasive treatment.
Is EBUS-TBNA a promising treatment for lung cancer?Yes, EBUS-TBNA is a promising treatment for lung cancer. It is a minimally invasive procedure that helps doctors accurately diagnose and stage lung cancer by examining lymph nodes. This can lead to better treatment planning and outcomes for patients.238911
What safety data is available for EBUS-TBNA in lung cancer treatment?EBUS-TBNA is generally considered a safe and minimally invasive procedure for diagnosing and staging lung cancer. However, complications, though rare, have been reported. These include mediastinitis, pericarditis, pneumothorax, and bleeding. A nationwide survey in Japan and various case reports highlight that while the procedure is widely used and complications are infrequent, they can occur, especially in specific patient populations such as those who have recently undergone percutaneous coronary intervention.4571014
What data supports the idea that EBUS-TBNA for Lung Cancer is an effective treatment?The available research shows that EBUS-TBNA is a useful tool for diagnosing and staging lung cancer, particularly non-small cell lung cancer. It is a minimally invasive method that helps in identifying cancer spread to lymph nodes. Although one study suggests that EBUS guidance improves the results of the procedure compared to standard methods, it hasn't been proven to be superior in a randomized trial. Another study highlights its role in diagnosing lymph node metastasis, which is crucial for treatment planning. Overall, EBUS-TBNA is effective in providing important diagnostic information for lung cancer management.1691213
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, it excludes patients planning to receive certain therapies like conventional radiotherapy, chemotherapy, or surgery, except at disease progression.
Eligibility Criteria
This trial is for adults over 18 with confirmed non-small cell lung cancer who can't have surgery or chose not to. They should be in fair health (performance status 0-2), have early-stage T1-2 disease without distant metastasis, and need EBUS-TBNA staging before SBRT treatment. Pregnant women, those unfit for bronchoscopy, or planning other treatments are excluded.Inclusion Criteria
I can take care of myself and am up and about more than 50% of my waking hours.
I cannot undergo surgery for my condition.
I am 18 years old or older.
My cancer is confirmed as non-small cell lung cancer through testing.
My cancer is in an early stage and hasn't spread far.
I have chosen not to undergo surgery for my condition.
Exclusion Criteria
I currently have an infection in my body, lungs, or around my heart.
I am unable to understand and agree to the study's details.
Treatment Details
The trial tests the use of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) for lymph node staging in patients with lung cancer who will undergo Stereotactic Body Radiotherapy (SBRT). It aims to provide a less invasive option for accurate diagnosis and treatment planning.
1Treatment groups
Experimental Treatment
Group I: EBUS-TBNAExperimental Treatment1 Intervention
EBUS-TBNA is already approved in European Union, United States, Japan for the following indications:
🇪🇺 Approved in European Union as EBUS-TBNA for:
- Mediastinal and hilar lymph node staging for non-small cell lung cancer
🇺🇸 Approved in United States as EBUS-TBNA for:
- Mediastinal and hilar lymph node staging for non-small cell lung cancer
🇯🇵 Approved in Japan as EBUS-TBNA for:
- Mediastinal and hilar lymph node staging for non-small cell lung cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Toronto General HospitalToronto, Canada
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
References
Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial. [2022]Our group performed a randomized trial to assess whether the addition of endobronchial ultrasound (EBUS) guidance will lead to better results than standard transbronchial needle aspiration (TBNS). EBUS guidance seems to be beneficial in increasing the yield of TBNA but has not been proven to be superior to conventional procedures in a randomized trial.
The utility of sonographic features during endobronchial ultrasound-guided transbronchial needle aspiration for lymph node staging in patients with lung cancer: a standard endobronchial ultrasound image classification system. [2022]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure with a high yield for lymph node staging of lung cancer. The aim of this study was to assess the utility of sonographic features of lymph nodes during EBUS-TBNA for the prediction of metastasis in patients with lung cancer and to establish a standard endobronchial ultrasound (EBUS) image classification system.
Efficacy of convex probe endobronchial ultrasound (CP-EBUS) assisted transbronchial needle aspiration for mediastinal staging in non-small cell lung cancer cases with mediastinal lymphadenopathy. [2019]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a sampling method for the patients with non-small cell lung cancer (NSCLC) that have enlarged mediastinal lymph nodes that are detected with computed tomography (CT). We aimed to investigate the value of EBUS-TBNA in sampling enlarged mediastinal lymph nodes in the patient with NSCLC.
[A case of acute mediastinitis after endobronchial needle aspiration]. [2013]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has become widespread, but reports of complications are rare.
Complications associated with endobronchial ultrasound-guided transbronchial needle aspiration: a nationwide survey by the Japan Society for Respiratory Endoscopy. [2022]With the recent widespread use of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), there have been occasional reports on complications associated with its use. Previous reviews on EBUS-TBNA have been limited to studies by skilled operators, thus the results may not always be applicable to recent clinical practice. To assess the safety of EBUS-TBNA for the staging and diagnosis of lung cancer in Japan, a nationwide survey on its current usage status and complications associated with its use was conducted by the Japan Society for Respiratory Endoscopy (JSRE).
Endobronchial ultrasound-guided transbronchial needle aspiration for systematic nodal staging of lung cancer in patients with N0 disease by computed tomography and integrated positron emission tomography-computed tomography. [2016]Data regarding the sensitivity of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for staging of lung cancer in patients with radiographic N0 disease is scant and inconsistent. With increasing use of nonoperative ablative therapies, studies focusing on the performance characteristics of EBUS-TBNA in this population are important.
Severe Complications of Ultrasound Guided Transbronchial Needle Aspiration--A Case Series and Review of the Literature. [2017]Endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) has become essential for the workup of patients with lung cancer and other pulmonary diseases. The emphasis of currently available literature is related to the diagnostic yield of EBUS-TBNA which was found to be high. Complications seem to be rare but such data are scant. We report three cases of complications including mediastinitis, pneumothorax and bleeding and provide a review on the existing literature.
A Multicenter Feasibility Study of EBUS-TBNA for Potentially Operable Non-Small Cell Lung Cancer: The JMTO LC07-02 Study (UMIN000001280). [2017]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard procedure for the pathological evaluation of the mediastinal nodal (N2) status of lung cancer; however, its feasibility in potentially operable patients with suspicion of minimal N2 disease remains unestablished.
Roles of EBUS-TBNA in non-small cell lung cancer. [2019]Endobronchial ultrasound-guided transbronchial aspiration (EBUS-TBNA) has the potential to improve nodal diagnosis and staging in non-small cell lung cancer (NSCLC). This study was performed to explore the roles of EBUS-TBNA in NSCLC.
Safety of endobronchial ultrasound-guided transbronchial needle aspiration in patients with lung cancer within a year after percutaneous coronary intervention. [2019]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) may be necessary for patients with incidental lung cancer during or after coronary intervention. Although EBUS-TBNA is quite safe, the safety in patients who recently received percutaneous coronary intervention (PCI) has not been demonstrated. The aim of this study was to assess the safety of EBUS-TBNA in patients with lung cancer who underwent PCI within one year.
A pragmatic application of endobronchial ultrasound-guided transbronchial needle aspiration: a single institution experience. [2020]Endobronchial ultrasound-guided trans-bronchial needle aspiration (EBUS-TBNA) is minimally invasive technique used for diagnosis and/or staging of benign and malignant pulmonary and non-pulmonary disease. Previous studies have established the utility of EBUS-TBNA in narrowly defined indications and populations. In this pragmatic 'real world' study we have analysed the use of EBUS-TBNA for a variety of clinical presentations and its clinical application in conjunction with other invasive investigations.
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Of Mediastinal And Hilar Lymph Nodes- Five Years Of Experience At A Cancer Setting Hospital In Pakistan. [2020]Endobronchial Ultrasound (EBUS) guided Transbronchial needle aspiration (TBNA) offers a minimally invasive diagnostic tool for mediastinal lymphadenopathy (ML). This study is done with the objective to determine the diagnostic utility of EBUS TBNA for ML in cancer and non-cancer patients.
Comparison of the efficiency of endobronchial ultrasound-guided transbronchial needle aspiration using a 22G needle versus 25G needle for the diagnosis of lymph node metastasis in patients with lung cancer: a prospective randomized, crossover study. [2022]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is generally performed for the diagnosis of hilar/mediastinal lymph node metastasis in patients with lung cancer. Recently, a 25-gauge (G) needle became available, but robust evidence of its usefulness in routine clinical practice is still lacking.
Severe mediastinitis and pericarditis after endobronchial ultrasound-guided transbronchial needle aspiration: A case report. [2022]Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a safe and minimally invasive diagnostic tool for mediastinal and hilum evaluation. However, infectious complications may occur after EBUS-TBNA. Among these, mediastinitis and pericarditis are rare.