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

NCT06123312 | Completed

• 1 other identifier: 2310-020-132
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Nodule

Keywords

Radial Probe Endobronchial Ultrasound; Pulmonary Nodule; Forceps Biopsy; Needle Aspiration; Cryobiopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diagnostic yield based on clinical diagnosis

  Time Frame: up to 6 months

• Adverse events

  Time Frame: up to 1 week

Other Outcomes (7)

• Radial endobronchial ultrasound probe orientation

  Time Frame: up to 1 day

• Procedure time in minutes and seconds

  Time Frame: up to 1 day

• Diameter of cryoprobe

  Time Frame: up to 1 day

Study Arms (1)

Single intervention arm: Tri-modality biopsy

EXPERIMENTAL

Patients enrolled in this single arm will have lung nodules biopsied by Tri-modality (forceps biopsy, needle aspiration, and cryobiopsy)

Diagnostic Test: Tri-modality biopsy

Interventions

Tri-modality biopsy DIAGNOSTIC_TEST

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

Single intervention arm: Tri-modality biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
• Age ≥ 18
• Written informed consent after participant's information

You may not qualify if:

• Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
• Pure GGO lesion
• Patients at increased risk of bleeding
• Cannot stop agents such as antiplatelet agent or anticoagulant therapy
• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead
• Erbe-med: collaborator

Study Sites (1)

Pusan National University hospital

Busan, 49241, South Korea

Location

Study Officials

• Jung Seop Eom, MD, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: October 4, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)