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

Not Applicable

Active, not recruiting

• Conditions: Lung Nodule
• Interventions: Diagnostic Test: Transbronchial cryobiopsy

• Registration Number: NCT05046093
• Lead Sponsor: Pusan National University Hospital

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.

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 Timeline

• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-16
• Study Start: 2021-12-01
• Primary Completion: 2022-07-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-04
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single intervention arm - transbronchial cryobiopsy	Transbronchial cryobiopsy	Patients enrolled in this single arm will have lung nodules biopsied by transbronchial cryobiopsy.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield based on pathologic diagnosis	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 Outcome Measures

Name	Time	Method
Diagnostic yield based on clinical diagnosis	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.
Adverse events	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).

Trial Locations

Locations (1)

Pusan National University hospital; 🇰🇷 Busan, Korea, Republic of