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

NCT05046093 | Completed

• 1 other identifier: 2105-045-103
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Nodule

Keywords

Cryobiopsy; Pulmonary nodule; Radial EBUS

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 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 Outcomes (2)

• Diagnostic yield based on clinical diagnosis

  up to 6 months

• Adverse events

  up to 1 week

Other Outcomes (8)

• Type of bronchoscope

  up to 1 day

• Guide sheath use

  up to 1 day

• Radial endobronchial ultrasound probe orientation

  up to 1 day

Study Arms (1)

Single intervention arm - transbronchial cryobiopsy

EXPERIMENTAL

Patients enrolled in this single arm will have lung nodules biopsied by transbronchial cryobiopsy.

Diagnostic Test: Transbronchial cryobiopsy

Interventions

Transbronchial cryobiopsy DIAGNOSTIC_TEST

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.

Single intervention arm - transbronchial cryobiopsy

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

Study Sites (1)

Pusan National University hospital

Busan, 49241, South Korea

Location

Related Publications (1)

• Kim SH, Mok J, Kim S, Yoo WH, Jo EJ, Kim MH, Lee K, Kim KU, Park HK, Lee MK, Eom JS. Clinical outcomes of transbronchial cryobiopsy using a 1.1-mm diameter cryoprobe for peripheral lung lesions - A prospective pilot study. Respir Med. 2023 Oct;217:107338. doi: 10.1016/j.rmed.2023.107338. Epub 2023 Jun 26.

  PMID: 37380091 DERIVED

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: August 18, 2021
• First Posted: September 16, 2021
• Study Start: December 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2023
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)