Interstitial Lung Disease (ILD)NCT06741826
Confocal Laser Endomicroscopy Guided Cryobiopsy in the Diagnosis of Interstitial Lung Disease
A study testing pCLE-guided transbronchial lung cryobiopsy and Fluoroscopy-guided transbronchial lung cryobiopsy in people with Interstitial Lung Disease (ILD), run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This prospective, single-center, randomized controlled trial compares pCLE-guided TBLC with conventional TBLC in patients with suspected interstitial lung disease. The study evaluates whether pCLE guidance improves diagnostic performance and procedural safety, with outcomes including final diagnosis and biopsy-related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- pCLE-guided transbronchial lung cryobiopsy and Fluoroscopy-guided transbronchial lung cryobiopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2025to 27 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- Contraindications to bronchoscopy or TBLC.
- Severe hypoxemia or uncontrolled bleeding risk.
- Severe pulmonary hypertension or unstable cardiopulmonary disease.
- Active infection.
- Pregnancy.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diagnostic Performance and Safety of Confocal Laser Endomicroscopy Guided Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease: a Randomised Controlled Trial
This prospective, single-center, randomized controlled trial compares pCLE-guided TBLC with conventional TBLC in patients with suspected interstitial lung disease. The study evaluates whether pCLE guidance improves diagnostic performance and procedural safety, with outcomes including final diagnosis and biopsy-related complications.
Read the detailed description
Patients with suspected ILD undergo multidisciplinary evaluation before enrollment and are included when clinical and HRCT findings are insufficient for a definitive diagnosis and histopathological assessment by TBLC is considered necessary. Participants are randomized 1:1 to pCLE-guided TBLC or conventional TBLC. In both groups, biopsy targets are selected according to HRCT and multidisciplinary assessment, and TBLC is performed following established recommendations. In the pCLE-guided group, pCLE is additionally used within the predefined target area before biopsy to assist selection of suitable sampling sites. Histopathological assessment is performed by blinded pulmonary pathologists, and final diagnoses are established through post-biopsy multidisciplinary discussion integrating clinical, radiological, bronchoscopic, and pathological information.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- pCLE-guided transbronchial lung cryobiopsy, Fluoroscopy-guided transbronchial lung cryobiopsy
- Keywords
- probe-based confocal laser endomicroscopy, pCLE, transbronchial lung cryobiopsy, TBLC, interstitial lung disease, ILD
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCLE-guided transbronchial lung cryobiopsyProcedure or surgery
Probe-based confocal laser endomicroscopy is used before TBLC to assist biopsy-site selection within the predefined target region.
Fluoroscopy-guided transbronchial lung cryobiopsyProcedure or surgery
TBLC is performed at biopsy sites selected according to conventional clinical and radiological assessment without pCLE guidance.
| Study group | Role | What they receive |
|---|---|---|
| pCLE-guided group | Experimental | Patients assigned to this group undergo transbronchial lung cryobiopsy (TBLC) with probe-based confocal laser endomicroscopy (pCLE) guidance. Before bronchoscopy, the target lobe and bronchial segment are determined according to high-resolution computed tomography findings and multidisciplinary evaluation. During the procedure, pCLE is performed within the predefined target region to assess the distal lung parenchyma and assist in selecting an appropriate biopsy site. The pCLE probe is advanced into the distal lung parenchyma for assessment. After pCLE evaluation, TBLC is performed with the cryoprobe positioned approximately 1-2 cm from the pleura. Areas considered suitable for tissue sampling are preferentially selected while potentially unfavorable regions are avoided when feasible. After pCLE assessment, the probe is withdrawn and TBLC is performed at the selected site according to standard procedures. Receives: Procedure: pCLE-guided transbronchial lung cryobiopsy |
| Fluoroscopy-guided TBLC | Experimental | Patients assigned to this group undergo fluoroscopy-guided transbronchial lung cryobiopsy (TBLC). Before bronchoscopy, the target lobe and bronchial segment are determined according to high-resolution computed tomography findings and multidisciplinary evaluation. TBLC is performed within the predefined target region in accordance with published international expert consensus recommendations. Biopsy specimens are subsequently evaluated by histopathology and multidisciplinary discussion. Receives: Procedure: Fluoroscopy-guided transbronchial lung cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDD diagnostic yield after TBLC
MDD diagnostic yield after TBLC, defined as the proportion of participants with a specific final diagnosis established by post-biopsy MDD.
Measured: 6 months
Secondary outcomes (1)
Occurrence of operation-related complications
Final diagnostic categories, biopsy specimen characteristics, bleeding severity and volume, hemostatic interventions, pneumothorax, and mortality within 7 days after TBLC.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start3 Dec 2025
- Primary completion20 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741826
- Sponsor's protocol ID
- 2022YFC2404404-1
- Status last verified
- Sep 2026
- First submitted
- 16 Dec 2024
- Last updated
- 8 Sep 2026
- Results posted
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Performance and Safety of Confocal Laser Endomicroscopy Guided Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06741826
- Acronym / sponsor ID
- 2022YFC2404404-1
- Conditions
- Interstitial Lung Disease (ILD)
- Keywords
- probe-based confocal laser endomicroscopy, pCLE, transbronchial lung cryobiopsy, TBLC, interstitial lung disease, ILD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 19 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 prospective, single-center, randomized controlled trial compares pCLE-guided TBLC with conventional TBLC in patients with suspected interstitial lung disease. The study evaluates whether pCLE guidance improves diagnostic performance and procedural safety, with outcomes including final diagnosis and biopsy-related complications.
Detailed description
Patients with suspected ILD undergo multidisciplinary evaluation before enrollment and are included when clinical and HRCT findings are insufficient for a definitive diagnosis and histopathological assessment by TBLC is considered necessary. Participants are randomized 1:1 to pCLE-guided TBLC or conventional TBLC. In both groups, biopsy targets are selected according to HRCT and multidisciplinary assessment, and TBLC is performed following established recommendations. In the pCLE-guided group, pCLE is additionally used within the predefined target area before biopsy to assist selection of suitable sampling sites. Histopathological assessment is performed by blinded pulmonary pathologists, and final diagnoses are established through post-biopsy multidisciplinary discussion integrating clinical, radiological, bronchoscopic, and pathological information.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pCLE-guided group | Experimental | Procedure: pCLE-guided transbronchial lung cryobiopsyPatients assigned to this group undergo transbronchial lung cryobiopsy (TBLC) with probe-based confocal laser endomicroscopy (pCLE) guidance. Before bronchoscopy, the target lobe and bronchial segment are determined according to high-resolution computed tomography findings and multidisciplinary evaluation. During the procedure, pCLE is performed within the predefined target region to assess the distal lung parenchyma and assist in selecting an appropriate biopsy site. The pCLE probe is advanced into the distal lung parenchyma for assessment. After pCLE evaluation, TBLC is performed with the cryoprobe positioned approximately 1-2 cm from the pleura. Areas considered suitable for tissue sampling are preferentially selected while potentially unfavorable regions are avoided when feasible. After pCLE assessment, the probe is withdrawn and TBLC is performed at the selected site according to standard procedures. |
| Fluoroscopy-guided TBLC | Experimental | Procedure: Fluoroscopy-guided transbronchial lung cryobiopsyPatients assigned to this group undergo fluoroscopy-guided transbronchial lung cryobiopsy (TBLC). Before bronchoscopy, the target lobe and bronchial segment are determined according to high-resolution computed tomography findings and multidisciplinary evaluation. TBLC is performed within the predefined target region in accordance with published international expert consensus recommendations. Biopsy specimens are subsequently evaluated by histopathology and multidisciplinary discussion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Contraindications to bronchoscopy or TBLC.
- Severe hypoxemia or uncontrolled bleeding risk.
- Severe pulmonary hypertension or unstable cardiopulmonary disease.
- Active infection.
- Pregnancy.
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 |
|---|---|---|
| pCLE-guided transbronchial lung cryobiopsyProbe-based confocal laser endomicroscopy is used before TBLC to assist biopsy-site selection within the predefined target region. | Procedure or surgery | pCLE-guided group |
| Fluoroscopy-guided transbronchial lung cryobiopsyTBLC is performed at biopsy sites selected according to conventional clinical and radiological assessment without pCLE guidance. | Procedure or surgery | Fluoroscopy-guided TBLC |
Primary outcome
MDD diagnostic yield after TBLC
Time frame: 6 months
MDD diagnostic yield after TBLC, defined as the proportion of participants with a specific final diagnosis established by post-biopsy MDD.
1 secondary outcome
Occurrence of operation-related complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Interstitial Lung Disease (ILD)
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
Radiation Pneumonitis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pCLE-guided transbronchial lung cryobiopsy and Fluoroscopy-guided transbronchial lung cryobiopsy in people with Interstitial Lung Disease (ILD), run by China-Japan Friendship Hospital at 1 site in China.
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 0 inclusion and 6 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: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MDD diagnostic yield after TBLC (time frame: 6 months). 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 8 Sep 2026.