Ultrasound-Guided Needle Aspiration for Lung Cancer

(EBUS-Suction Trial)

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Minors, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method to obtain better tissue samples from patients who might have lung cancer that has spread to their lymph nodes. It tests using an ultrasound-guided needle to take samples, both with and without extra suction, during a bronchoscopy (a procedure to look inside the lungs). The goal is to collect more tissue with less blood contamination. This trial may suit those whose CT scan suggests lung cancer spread to the lymph nodes and who are stable enough for a bronchoscopy. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance diagnostic techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on non-reversible anticoagulation (blood thinners that cannot be stopped), you may not be eligible to participate.

What prior data suggests that this ultrasound-guided needle aspiration technique is safe for obtaining lung cancer samples?

Research has shown that endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is very safe for patients. Studies have found it to be a minimally invasive method for collecting tissue samples, using small tools and causing less harm to the body.

The procedure has been tested on various groups, including older adults, and is well-tolerated. Reports indicate a strong safety record with very few side effects. It is often used to check and stage lung cancer due to its accuracy and safety.

The successful use of EBUS-TBNA in medical settings suggests that its safety is well-established. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound-guided needle aspiration technique for lung cancer because it offers a potentially more precise method of diagnosing tumors in the lungs. Unlike traditional methods that might rely solely on bronchoscopy, this technique uses endobronchial ultrasound (EBUS) to guide the needle accurately to the tumor site, which could lead to better sample collection. Additionally, the use of vacuum assistance during the aspiration process might enhance the quality and quantity of the samples obtained, potentially improving diagnostic accuracy and leading to more tailored treatment plans for patients.

What evidence suggests that ultrasound-guided transbronchial needle aspiration is effective for lung cancer?

Research has shown that endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) reliably diagnoses lung cancer that may have spread nearby. Studies indicate this method is 90% accurate in diagnosing and staging non-small-cell lung cancer, a common type. In this trial, participants will undergo bronchoscopy with EBUS-TBNA, first without and then with applied vacuum, to assess its diagnostic effectiveness. EBUS-TBNA is safe and minimally invasive, involving less cutting or entering the body than other methods. It uses real-time ultrasound to guide tissue sampling, helping doctors determine how far the cancer has spread. This technique is well-established and trusted for its effectiveness in lung cancer cases. ^{1 4 5 6 7}

Who Is on the Research Team?

Peter Kneuertz, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with CT-scan findings that suggest lung cancer may have spread to lymph nodes and who are stable enough to undergo diagnostic procedures. It's not suitable for those who can't safely have a bronchoscopy.

Inclusion Criteria

I am healthy enough for a lung diagnostic procedure.

My CT scan shows possible lung cancer spread to lymph nodes.

Exclusion Criteria

I cannot undergo EBUS due to blood thinning medication that can't be stopped.

Pregnant female

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Patients undergo bronchoscopy with EBUS-TBNA first without and then with applied vacuum

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic procedure

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Bronchoscopy
• Ultrasound-Guided Transbronchial Needle Aspiration

Trial Overview The study is testing if using suction during an endobronchial ultrasound-guided needle biopsy (a way of taking tissue samples from the lungs) can get better samples by increasing the amount of material collected and reducing blood contamination.

How Is the Trial Designed?

Group I: Diagnostic (bronchoscopy with EBUS-TBNA with/without vacuum) Experimental Treatment 2 Interventions

Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.

Bronchoscopy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Bronchoscopy for:

• Diagnostic purposes
• Therapeutic interventions
• Airway management

Approved in European Union as Bronchoscopy for:

• Diagnostic purposes
• Therapeutic interventions
• Airway management

Approved in Canada as Bronchoscopy for:

• Diagnostic purposes
• Therapeutic interventions
• Airway management

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

A case report highlights a rare complication of endobronchial ultrasound-guided trans-bronchial needle aspiration (EBUS-TBNA), where a 65-year-old man developed a subcarinal hematoma and hemoptysis after the procedure, likely due to puncture of a bronchial artery.

The complication occurred during a transition between anticoagulant treatments, suggesting that special caution is needed when performing EBUS-TBNA in patients undergoing changes in anticoagulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mediastinal haematoma: A little known complication of ultrasound-guided trans-bronchial lymph node aspiration (EBUS-TBNA)]. Fedi, A., Thony, F., Ferretti, GR., et al.[2019]

In a study of 15 lesions, EBUS-TBNA was successfully performed in 11 cases, demonstrating that the procedure is feasible in bronchi with a mean internal diameter of at least 4.5 mm.

No complications were reported during the procedure, indicating that EBUS-TBNA is a safe method for diagnosing lesions adjacent to narrow bronchi.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The usefulness of endobronchial ultrasonography-guided transbronchial needle aspiration at the lobar, segmental, or subsegmental bronchus smaller than a convex-type bronchoscope. Kurimoto, N., Inoue, T., Miyazawa, T., et al.[2022]

Endobronchial ultrasound guided transbronchial needle aspiration (EBUS TBNA) is effective in diagnosing lung cancer and assessing mediastinal lymph nodes, with a significant finding of malignancy in 44.9% of the patients studied (158 total).

The use of EBUS TBNA can potentially reduce the need for more invasive procedures like mediastinoscopy by up to 59.5%, indicating its important role in clinical practice guidelines for lung cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of endobroncial ultrasound guided transbrocnhial needle aspiration on clinical practice guideline. Tscheikuna, J., Disayabutr, S.[2016]

A 67-year-old man developed acute mediastinitis 13 days after undergoing EBUS-TBNA to diagnose an enlarged mediastinal lymph node, highlighting a rare but serious complication of the procedure.

Prompt treatment with antibiotics led to significant improvement in his symptoms and laboratory markers, emphasizing the importance of monitoring for complications after EBUS-TBNA, especially in cases involving necrotic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A case of acute mediastinitis after endobronchial needle aspiration]. Kurimoto, N., Shinmyo, T., Tagay, R., et al.[2013]

In a study of 132 patients who underwent EBUS-TBNA, 29.5% were aged 70 and older, and despite having more comorbidities and worse overall health, these older patients experienced no increase in complications compared to younger patients.

The diagnostic performance of EBUS-TBNA was consistent across age groups, indicating that this procedure is safe and effective for elderly patients, regardless of their health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound transbronchial needle aspiration in elderly patients: safety and performance outcomes EBUS-TBNA in elderly. Olgun Yıldızeli, Ş., Tufan, A., Bozkurtlar, E., et al.[2022]

EBUS-TBNA is a safe and effective method for diagnosing enlarged mediastinal lymph nodes, successfully diagnosing lung cancer in 63% of the 52 patients studied, with a high sensitivity of 85%.

The procedure also aids in diagnosing sarcoidosis, providing valuable pathological information, although its sensitivity for this condition was lower at 56%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided transbronchial needle aspiration of undiagnosed mediastinal lymphadenopathy. Tian, Q., Chen, LA., Wang, HS., et al.[2016]

In a study of 6826 patients undergoing EBUS-TBNA, only 33 (0.48%) experienced infectious complications, primarily pneumonia and mediastinal infections, indicating that such complications are rare.

Risk factors for these infections included the presence of necrotic features in target lesions on CT scans and procedures performed via the esophagus, suggesting that careful evaluation of these factors is important for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious complications of EBUS-TBNA: A nested case-control study using 10-year registry data. Kang, N., Shin, SH., Yoo, H., et al.[2021]

In a study of 63 patients undergoing EBUS-TBNA, the use of a laryngeal mask for general anesthesia allowed for successful airway management and oxygenation without compromising the procedure's effectiveness, achieving an 87% informative rate for lymph node sampling.

The study demonstrated that 78% of cases could avoid more invasive mediastinoscopy, highlighting the laryngeal mask's role in enhancing patient comfort and procedural efficiency during EBUS-TBNA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anaesthesia for bronchial echoendoscopy: experience with the laryngeal mask]. Douadi, Y., Bentayeb, H., Malinowski, S., et al.[2019]

The study analyzed 1176 EBUS-TBNA samples from 486 patients over two years, achieving a diagnostic yield of 89.5% and a high sensitivity for malignancy at 95.69%, indicating that EBUS-TBNA is a highly effective method for diagnosing lung cancer.

The negative predictive value was 96.75%, suggesting that EBUS-TBNA is reliable in ruling out malignancy, while the overall inadequate sample rate was low at 10.5%, supporting its safety and efficacy as a minimally invasive diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EBUS-TBNA: A 2-Year Experience from a Tertiary Pathology Centre with Cyto-Histological Correlation. Vuorisalo, A., Pöyry, E., Kholová, I.[2022]

In a study involving 102 patients with suspected lung cancer metastasis, both 22-gauge (G) and 25G needles showed similar diagnostic yields for detecting malignancy (75% each), indicating that either needle can be effectively used for EBUS-TBNA.

However, the 22G needle provided significantly larger tissue samples and a higher number of malignant cells compared to the 25G needle, suggesting it is the preferred choice for better specimen quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sakai, T., Udagawa, H., Kirita, K., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4367563/

Endobronchial ultrasound-guided transbronchial needle ... EBUS-TBNA is a novel, minimally invasive method to sample peribronchial masses using real-time guidance.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0954611125003026

Endobronchial ultrasound-guided transbronchial needle ... A meta-analysis that examined the EBUS-TBNA diagnosis system for mediastinal staging of non-small-cell lung cancer (NSCLC) reported 90 % diagnostic accuracy and ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0208992

Results of a French prospective multicenter trial (EVIEPEB) This two-step study evaluated the cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for presurgery staging of ...

4. publications.ersnet.org publications.ersnet.org/content/erj/33/5/1156

Effectiveness and safety of endobronchial ultrasound ... Endobronchial ultrasound-guided transbronchial needle aspiration is a safe and highly accurate procedure for the examination and staging of mediastinal and ...

5. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.201311-2007CI

Endobronchial Ultrasound–guided Transbronchial Needle ... Real-time endobronchial ultrasound–guided transbronchial needle aspiration (EBUS-TBNA) is an established technique for invasive mediastinal staging of non– ...

6. mdpi.com mdpi.com/2075-4418/13/8/1405

Safety and Diagnostic Accuracy of the Transnasal ... Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is an extremely safe [1] and accurate endoscopic procedure widely ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9200877/

Safety and efficacy of endobronchial ultrasound‐guided ... The safety and efficacy of endobronchial ultrasound‐guided transbronchial needle aspiration (EBUS‐TBNA) in patients aged 70 years and older ...