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

Pusan National University Hospital50 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Nodule

Interventions

Transbronchial cryobiopsyDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University hospital

Busan, South Korea

Outcomes

Primary Outcomes

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.

Time frame: up to 6 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: up to 1 week

Data from ClinicalTrials.gov

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