Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered), Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered).
- Who it may be relevant to
- Registry conditions: Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cryobiopsy-centered Versus Forceps Biopsy-centered Sampling for the Diagnosis of Peripheral Pulmonary Lesions - a Multicenter Prospective Randomized Controlled Trial
Overview
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 test 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. - Diagnostic test 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.
Primary outcome measures
- The overall cumulative diagnostic yield [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (5)
- Diagnosis Rate According to Lesion Size [Time frame: through study completion, an average of 1 year]
- Diagnosis Rate According to Malignant and Benign Disease Classification [Time frame: through study completion, an average of 1 year]
- Diagnosis Rate According to Bronchus Sign [Time frame: through study completion, an average of 1 year]
- Diagnosis Rate According to Image Classification Detected by Radial Bronchial Endoscopic Ultrasound (RP-EBUS) [Time frame: through study completion, an average of 1 year]
- Complication Rate [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
South Korea · 3 centers
- Pusan National University Hospital — Busan
- Yeungnam University Medical Center — Daegu
- Chungnam National University Hospital — Daejeon
Identifiers
NCT: NCT06752395 · 2306-027-128