Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions

Lung Nodule Clinical Trial

Official title:

Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions- A Prospective Observational Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123312
• Other study ID #: 2310-020-132
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Pusan National University Hospital
• Contact: Jung Seop Eom, MD, PhD
• Phone: 82-51-240-7889
• Email: ejspulm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As the former radial probe endobronchial ultrasound (RP-EBUS) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.

Description:

This is a prospective, single-arm, open-label trial designed to assess the diagnostic accuracy and safety of the Tri-modality (forceps biopsy, needle aspiration, and transbronchial cryobiopsy) biopsy in patients with peripheral pulmonary nodules.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy

• Age = 18

• Written informed consent after participant's information

Exclusion Criteria:

• Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)

• Pure GGO lesion

• Patients at increased risk of bleeding

1. Cannot stop agents such as antiplatelet agent or anticoagulant therapy

2. Coagulopathy: Thrombocytopenia (< 100,000/mm3) or prolonged PT (INR > 1.5)

• Patient with existing or risk of pulmonary and cardiovascular decompensation

• Intolerance to sedation

• Vulnerable groups such as pregnant woman, breast feeding, etc.

• Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility

Related Conditions & MeSH terms

• Lung Nodule

Intervention

Diagnostic Test:
• Tri-modality biopsy
When the lung nodule is visualized by ultrathin bronchoscope (3mm) with RP-EBUS, Tri-modality biopsy is performed.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University hospital	Busan

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University Hospital	Erbe USA Incorporated

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radial endobronchial ultrasound probe orientation	Lesion orientation regarding radial endobronchial ultrasound probe is assessed as the following scale (a. within, concentric; b. within, eccentric; c. adjacent; d. invisible).	Time Frame: up to 1 day
Other	Procedure time in minutes and seconds	The time spent in procedure begins with the insertion of bronchoscope into vocal cord and ends with removal of bronchoscope from vocal cord.	Time Frame: up to 1 day
Other	Diameter of cryoprobe	Diameter of cryoprobe use is assessed as the following scale (a. 1.1mm; b. 1.7mm).	Time Frame: up to 1 day
Other	Number of forceps biopsy	The number of forceps biopsy samples is assessed.	Time Frame: up to 1 day
Other	Number of needle aspiration	The number of needle aspiration samples is assessed.	Time Frame: up to 1 day
Other	Freezing time of cryoprobe in seconds	The freezing time of cryoprobe for sampling the lesions is assessed in seconds.	Time Frame: up to 1 day
Other	Biopsy size in millimeter	Size of biopsy tissue is assessed by pathologist for maximum and minimum diameter in millimeter.	Time Frame: up to 1 month
Primary	Diagnostic yield based on pathologic diagnosis	Diagnostic yield based on pathologic diagnosis is defined as percentage of definitive pathological diagnosis by transbronchial Tri-modality biopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure.	Time Frame: up to 6 months
Secondary	Diagnostic yield based on clinical diagnosis	Diagnostic yield based on clinical diagnosis is defined as percentage of pathological diagnosis with suspicious results by transbronchial Tri-modality biopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure.	Time Frame: up to 6 months
Secondary	Adverse events	Occurrence of bleeding, pneumothorax, and infection events (during the procedure and within 1 week after the intervention). Bleeding will be assessed as the following scale (a. mild = self-limiting bleeding, manageable with suction alone and without the need for any specific intervention; b. moderate = use of any additional intervention such as instillation of ice-cold saline or vasoconstrictive drugs, or transient balloon tamponade, ; c. severe = additional prolonged monitoring or intensive care therapy after the procedure or if the bleeding was fatal). Pneumothorax will be assessed as the following scale (a. pneumothorax not requiring chest tube insertion; b. pneumothorax requiring chest tube insertion).	Time Frame: up to 1 week