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

Lung Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05046093
• Other study ID #: 2105-045-103
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: October 2022
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Nodule

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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