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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Nodule
• Intervention / Treatment: Diagnostic test: Tri-modality biopsy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung Seop Eom, MD, PhD; Phone Number: 82-51-240-7889; Email: ejspulm@gmail.com
• Study Contact Backup: Name: Hayoung Seong, MD; Phone Number: 82-51-240-7889; Email: goldskygod7@naver.com

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Recruiting
    • Pusan National University Hospital
    • Contact: Jung Seop Eom, MD, PhD; Phone Number: 82-51-240-7889; Email: ejspulm@gmail.com
    • Contact: Hayoung Seong, MD; Phone Number: 82-51-240-7889; Email: goldskygod7@naver.com
    • Principal Investigator: Jung Seop Eom, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single intervention arm: Tri-modality biopsy; 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; When the lung nodule is visualized by ultrathin bronchoscope (3mm) with RP-EBUS, Tri-modality biopsy is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of forceps biopsy	The number of forceps biopsy samples is assessed.	Time Frame: up to 1 day
Number of needle aspiration	The number of needle aspiration samples is assessed.	Time Frame: up to 1 day
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
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

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Collaborators: Erbe USA Incorporated
• Investigators: Principal Investigator: Jung Seop Eom, MD, PhD, Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cryobiopsy; Pulmonary Nodule; Forceps Biopsy; Needle Aspiration; Radial Probe Endobronchial Ultrasound
• Other Study ID Numbers: 2310-020-132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No