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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well endobronchial ultrasound-guided transbronchial needle-aspiration (EBUS-TBNA) with suction works in obtaining samples from patients with suspected lung cancer that has spread to the nodal. EBUS-TBNA samples obtained with additional suction may help to improve material-amounts and decrease blood contamination in the samples.

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 data supports the effectiveness of the treatment Ultrasound-Guided Needle Aspiration for Lung Cancer?

Research shows that EBUS-TBNA, a part of this treatment, is highly effective with a diagnostic rate of up to 93.6% and is minimally invasive, making it a safe and reliable method for diagnosing lung cancer and assessing lymph nodes. ^{1 2 3 4 5}

Is ultrasound-guided needle aspiration for lung cancer safe?

Ultrasound-guided needle aspiration, also known as EBUS-TBNA, is generally considered safe with low complication rates, estimated between 0.22% to 1.44%. While complications like infections and mediastinal haematoma (a type of bleeding in the chest area) are rare, the procedure is widely used and regarded as minimally invasive. ^{1 6 7 8 9}

How is the treatment EBUS-TBNA different from other treatments for lung cancer?

EBUS-TBNA is unique because it uses a special bronchoscope with an ultrasound probe to see and sample lymph nodes outside the airway in real-time, making it minimally invasive and safer compared to traditional methods. It allows for accurate diagnosis of lymph node metastasis in lung cancer, which is not possible with conventional bronchoscopy. ^{1 3 4 5 10}

Research Team

Peter Kneuertz, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

Pregnant female

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

Prisoners

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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 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]

References

1. United States 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. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Anaesthesia for bronchial echoendoscopy: experience with the laryngeal mask]. [2019]

3. Thailand pubmed.ncbi.nlm.nih.gov

Impact of endobroncial ultrasound guided transbrocnhial needle aspiration on clinical practice guideline. [2016]

4. China pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound-guided transbronchial needle aspiration of undiagnosed mediastinal lymphadenopathy. [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

EBUS-TBNA: A 2-Year Experience from a Tertiary Pathology Centre with Cyto-Histological Correlation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound transbronchial needle aspiration in elderly patients: safety and performance outcomes EBUS-TBNA in elderly. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Infectious complications of EBUS-TBNA: A nested case-control study using 10-year registry data. [2021]

8. France pubmed.ncbi.nlm.nih.gov

[Mediastinal haematoma: A little known complication of ultrasound-guided trans-bronchial lymph node aspiration (EBUS-TBNA)]. [2019]

9. Japan pubmed.ncbi.nlm.nih.gov

[A case of acute mediastinitis after endobronchial needle aspiration]. [2013]

10. China 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. [2022]