Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study

As the former radial endobronchial ultrasound (R-EBUS) guided transbronchial forcep biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique, transbronchial cryobiopsy, in patients with peripheral pulmonary nodules.

Study Overview

• Status: Completed
• Conditions: Lung Nodule
• Intervention / Treatment: Diagnostic test: Transbronchial cryobiopsy

Detailed Description

This is a prospective, single arm, open label trial to assess the diagnostic accuracy and safety of the transbronchial cryobiopsy in patients with peripheral pulmonary nodule using a 1.1mm cryoprobe, combined with bronchoscope (with/without guide sheath), R-EBUS, virtual bronchoscopy navigation, and fluoroscopy.

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

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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 - transbronchial cryobiopsy; Patients enrolled in this single arm will have lung nodules biopsied by transbronchial cryobiopsy.	Diagnostic test: Transbronchial cryobiopsy; When the lung nodule is visualized by thin bronchoscope (4mm) with R-EBUS, cryobiopsy is performed. If not visualized, ultrathin (3mm) bronchoscope is used. Cryobiopsy is performed with 1.1mm cryo-probe.

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 cryobiopsy. 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.	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 cryobiopsy. 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.	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, transient balloon tamponade, or therapeutic bronchoscope (external diameter 6mm); 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).	up to 1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of bronchoscope	Type of bronchoscope used is assessed as the following scale (a. thin; b. ultrathin).	up to 1 day
Guide sheath use	Guide sheath use is assessed as the following scale (a. yes; b. no).	up to 1 day
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).	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.	up to 1 day
Diameter of cryoprobe	Diameter of cryoprobe use is assessed as the following scale (a. 1.1mm; b. 1.7mm).	up to 1 day
Number of biopsy	The number of biopsy samples is assessed.	up to 1 day
Freezing time of cryoprobe in seconds	The freezing time of cryoprobe for sampling the lesions is assessed in seconds.	up to 1 day
Biopsy size in millimeter	Size of biopsy tissue is assessed by pathologist for maximum and minimum diameter in millimeter.	up to 1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Cryobiopsy; Radial EBUS; Pulmonary nodule
• Other Study ID Numbers: 2105-045-103

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
• product manufactured in and exported from the U.S.: No