Lung Cancer (NSCLC)
Conditions
Keywords
Bronchoscpy, Cryobiopsy, Forceps biopsy, Lung cancer, Radial probe EBUS
Brief summary
This multicenter clinical trial evaluates the diagnostic yields of cryobiopsy and forceps biopsy for peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, supplemented by forceps biopsy. Conversely, in the forceps biopsy group, forceps biopsy is the primary method, supplemented by cryobiopsy. The study also explores the complementary relationship between the two methods and examines differences in diagnostic rates based on the order in which the procedures are performed.
Detailed description
This is a multi center, clinical trial evaluating the diagnostic yields of cryobiopsy and forceps biopsy methods used for the biopsy of peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, with forceps biopsy used as an auxiliary technique, while in the forceps biopsy group, forceps biopsy is the primary method, with cryobiopsy as the auxiliary technique. The study also investigates the complementary relationship between these biopsy methods and evaluates differences in diagnostic rates based on the sequence of the procedures.
Interventions
DIAGNOSTIC_TESTTransbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered)
When the lung nodule is visualized by bronchoscope using RP-EBUS, cryobiopsy is performed, followed by forceps biopsy.
DIAGNOSTIC_TESTTransbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)
When the lung nodule is visualized by bronchoscope using RP-EBUS, forceps biopsy is performed, followed by cryobiopsy.
Sponsors
Erbe-med
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Due to the nature of the procedures, blinding is not feasible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Obtained written informed consent * Subjects having \<30mm nodule on computed tomography * Subjects without contraindication to brochoscopy
Exclusion criteria
* Patients with central lesions that can be visually confirmed by bronchoscopy or those with suspicious findings of cancer metastasis in the mediastinal lymph nodes, who do not require radial bronchial endoscopic ultrasound (RP-EBUS). * Patients who cannot discontinue medications that increase bleeding risk, such as antiplatelet agents or anticoagulants. * Patients with bleeding disorders (e.g., platelet count \< 100,000/mm³). * Patients with severe comorbidities (e.g., serious respiratory or cardiovascular diseases) that make bronchoscopy unsafe. * Patients with hypersensitivity or allergies to drugs commonly used in endoscopic procedures, including lidocaine, midazolam, fentanyl, or flumazenil. * Pregnant or breastfeeding patients. * Patients with confirmed lung cancer undergoing rebiopsy for genetic testing or other purposes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The overall cumulative diagnostic yield | through study completion, an average of 1 year | Pathologic diagnostic yield of primary method and overall procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis Rate According to Lesion Size | through study completion, an average of 1 year | This outcome measures the diagnostic success rate based on the size of the peripheral lung nodule. Lesions are categorized by size (e.g., \<20 mm, 20 mm-30mm) to determine whether lesion size affects the accuracy and success of the biopsy method. |
| Diagnosis Rate According to Malignant and Benign Disease Classification | through study completion, an average of 1 year | This measures the diagnostic yield of cryobiopsy and forceps biopsy by differentiating between malignant and benign lesions. The diagnostic rate is compared between cases of cancerous and non-cancerous nodules to assess the performance of the biopsy methods in each category. |
| Diagnosis Rate According to Bronchus Sign | through study completion, an average of 1 year | The bronchus sign refers to whether or not the lesion is connected to a bronchus, as seen on imaging. This outcome evaluates whether the presence or absence of a bronchus sign impacts the diagnostic success of the biopsies. |
| Diagnosis Rate According to Image Classification Detected by Radial Bronchial Endoscopic Ultrasound (RP-EBUS) | through study completion, an average of 1 year | This outcome assesses the diagnostic rate based on the characteristics of the lesion as identified by RP-EBUS imaging (e.g., solid, partially solid, or ground-glass opacities). The study evaluates whether different imaging characteristics influence the biopsy's diagnostic accuracy. |
| Complication Rate | through study completion, an average of 1 year | This outcome measures the incidence of complications (e.g., bleeding, pneumothorax) that occur during or after the biopsy procedure. The complication rates are compared between the two biopsy methods to evaluate their safety profiles. |
Countries
South Korea
Outcome results
None listed