Lung Cancer (NSCLC)NCT06752395
Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions
A study testing Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered) and Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered) in people with Lung Cancer (NSCLC), run by Pusan National University Hospital at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered) and Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 1 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Obtained written informed consent
- Subjects having <30mm nodule on computed tomography
- Subjects without contraindication to brochoscopy
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites
Pusan National University Hospital
Busan
Yeungnam University Medical Center
Daegu
Chungnam National University Hospital
Daejeon
About this study
Official title: Cryobiopsy-centered Versus Forceps Biopsy-centered Sampling for the Diagnosis of Peripheral Pulmonary Lesions - a Multicenter Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered), Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)
- Keywords
- Bronchoscpy, Cryobiopsy, Forceps biopsy, Lung cancer, Radial probe EBUS
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered)Diagnostic test
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)Diagnostic test
When the lung nodule is visualized by bronchoscope using RP-EBUS, forceps biopsy is performed, followed by cryobiopsy.
| Study group | Role | What they receive |
|---|---|---|
| Cryobiopsy | Experimental | Cryobiopsy Group (Primary: Cryobiopsy, Auxiliary: Forceps Biopsy) In this group, cryobiopsy is performed as the primary biopsy method for sampling peripheral lung nodules. After the cryobiopsy is completed, forceps biopsy is conducted as an auxiliary method to obtain additional tissue samples. Receives: Diagnostic Test: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered) |
| Forceps biopsy | Experimental | Forceps Biopsy Group (Primary: Forceps Biopsy, Auxiliary: Cryobiopsy) In this group, forceps biopsy is performed as the primary biopsy method for sampling peripheral lung nodules. Following the forceps biopsy, cryobiopsy is conducted as an auxiliary method to obtain additional tissue samples. Receives: Diagnostic Test: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall cumulative diagnostic yield
Pathologic diagnostic yield of primary method and overall procedures
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Diagnosis Rate According to Lesion Size
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.
Measured: through study completion, an average of 1 year
Diagnosis Rate According to Malignant and Benign Disease Classification
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.
Measured: through study completion, an average of 1 year
Diagnosis Rate According to Bronchus Sign
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.
Measured: through study completion, an average of 1 year
Diagnosis Rate According to Image Classification Detected by Radial Bronchial Endoscopic Ultrasound (RP-EBUS)
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.
Measured: through study completion, an average of 1 year
Complication Rate
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe-med
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752395
- Sponsor's protocol ID
- 2306-027-128
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryobiopsy-centered Versus Forceps Biopsy-centered Sampling for the Diagnosis of Peripheral Pulmonary Lesions - a Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06752395
- Acronym / sponsor ID
- 2306-027-128
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Bronchoscpy, Cryobiopsy, Forceps biopsy, Lung cancer, Radial probe EBUS
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Collaborators
- Erbe-med
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryobiopsy | Experimental | Diagnostic Test: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered)Cryobiopsy Group (Primary: Cryobiopsy, Auxiliary: Forceps Biopsy) In this group, cryobiopsy is performed as the primary biopsy method for sampling peripheral lung nodules. After the cryobiopsy is completed, forceps biopsy is conducted as an auxiliary method to obtain additional tissue samples. |
| Forceps biopsy | Experimental | Diagnostic Test: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)Forceps Biopsy Group (Primary: Forceps Biopsy, Auxiliary: Cryobiopsy) In this group, forceps biopsy is performed as the primary biopsy method for sampling peripheral lung nodules. Following the forceps biopsy, cryobiopsy is conducted as an auxiliary method to obtain additional tissue samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Obtained written informed consent
- Subjects having <30mm nodule on computed tomography
- Subjects without contraindication to brochoscopy
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cryobiopsy |
| 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. | Diagnostic test | Forceps biopsy |
Primary outcome
The overall cumulative diagnostic yield
Time frame: through study completion, an average of 1 year
Pathologic diagnostic yield of primary method and overall procedures
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered) and Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered) in people with Lung Cancer (NSCLC), run by Pusan National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall cumulative diagnostic yield (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.