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Confocal assisted interstitial lung diagnosis

Diagnosis of interstitial lung disease requiring pathological biopsy assisted by confocal microscopy endoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109243
Enrollment
Unknown
Registered
2025-09-16
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial lung disease requiring pathological biopsy, with patients with small pulmonary nodules as controls

Interventions

observation group:None

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age greater >=18 years old, regardless of gender. 2.According to ICH-GCP and local laws, sign and date an informed consent form before initiating any research related procedures during screening visits. 3.Patients diagnosed with interstitial lung disease through MDD who require frozen lung biopsy for further clarification of the diagnosis. 4.Can tolerate bronchoscopy under general anesthesia without any allergic reactions to anesthetic drugs. 5.Contraindications for non bronchoscopy examination. 6. patients who have never smoked or have quit smoking for more than 3 months. 7. patients who have not been diagnosed with acute exacerbations by researchers. 8.Patients who require bronchoscopy due to small pulmonary nodules as a control group. 9.Good compliance, willing to conduct inspections and follow up on time according to the requirements of the plan. 10.The subjects were informed of the research purpose, methods, and potential discomfort and risks, agreed to participate in the trial, and signed an informed consent form. 11.The researchers evaluated and approved the participants for inclusion.

Exclusion criteria

Exclusion criteria: 1.Individuals with contraindications for bronchoscopy examination. 2.Patients who are in the acute exacerbation phase on the day of screening or enrollment. 3.Screening includes patients who were infected on the day of enrollment, including those with bacterial, viral, fungal, or tuberculosis infections. 4.Pregnant women. 5.Individuals with mental illnesses who cannot be followed up on schedule. 6.After review by the researchers, it was deemed unsuitable for inclusion. 7.Patients who are unable to sign informed consent forms.

Design outcomes

Primary

MeasureTime frame
Differences in sensitivity between CLE and HRCT in diagnosing ILD;Differences in specificity between CLE and HRCT in diagnosing ILD;

Secondary

MeasureTime frame
Characteristics of ILD and CLE in normal patients;The safety of CLE in bronchoscopy examination of ILD patients;

Countries

China

Contacts

Public ContactLi qiuhong

Shanghai Pulmonary Hospital

qiuhongl@126.com+86 18721740608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026