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Completed

NCT Number: NCT05046093

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.

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Key information

Conditions

Lung Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University hospital

Busan, 49241, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic yield based on pathologic diagnosis

    Time frame: up to 6 months

    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.

Secondary outcomes

  1. Diagnostic yield based on clinical diagnosis

    Time frame: up to 6 months

    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.

  2. Adverse events

    Time frame: up to 1 week

    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).

Other outcomes

  1. Type of bronchoscope

    Time frame: up to 1 day

    Type of bronchoscope used is assessed as the following scale (a. thin; b. ultrathin).

  2. Guide sheath use

    Time frame: up to 1 day

    Guide sheath use is assessed as the following scale (a. yes; b. no).

  3. Radial endobronchial ultrasound probe orientation

    Time frame: up to 1 day

    Lesion orientation regarding radial endobronchial ultrasound probe is assessed as the following scale (a. within, concentric; b. within, eccentric; c. adjacent; d. invisible).

  4. Procedure time in minutes and seconds

    Time frame: up to 1 day

    The time spent in procedure begins with the insertion of bronchoscope into vocal cord and ends with removal of bronchoscope from vocal cord.

  5. Diameter of cryoprobe

    Time frame: up to 1 day

    Diameter of cryoprobe use is assessed as the following scale (a. 1.1mm; b. 1.7mm).

  6. Number of biopsy

    Time frame: up to 1 day

    The number of biopsy samples is assessed.

  7. Freezing time of cryoprobe in seconds

    Time frame: up to 1 day

    The freezing time of cryoprobe for sampling the lesions is assessed in seconds.

  8. Biopsy size in millimeter

    Time frame: up to 1 month

    Size of biopsy tissue is assessed by pathologist for maximum and minimum diameter in millimeter.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 16, 2021
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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