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Clinical Trials in South Korea / NCT06752395
Enrolling by invitation Not applicable

Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions

NCT06752395 · tracked via the Priya Life Science South Korea tracker
Sponsor
Pusan National University Hospital
Phase
Not applicable
Started
2024-11-01
Last updated
2025-01-03

Condition(s) studied

Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered)Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)

Transbronchial 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.

Transbronchial 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • The overall cumulative diagnostic yield — through study completion, an average of 1 year
    Pathologic diagnostic yield of primary method and overall procedures

Trial sites (3)

FacilityCityRegionStatus
Pusan National University Hospital Busan South Korea
Yeungnam University Medical Center Daegu South Korea
Chungnam National University Hospital Daejeon South Korea

More Pusan National University Hospital trials in South Korea

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Other trials for the same condition

A Study of PHN-012 in Patients With Advanced Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06752395 on ClinicalTrials.gov ↗ ← All trials in South Korea