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Prospective research on the feasibility, efficacy and safety of transbronchial cryobiopsy for the precision diagnosis of children's interstitial lung disease

Prospective research on the feasibility, efficacy and safety of transbronchial cryobiopsy for the precision diagnosis of children's interstitial lung disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073581
Enrollment
Unknown
Registered
2023-07-14
Start date
2023-07-15
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

children's interstitial lung disease

Interventions

Gold Standard: Children younger than 2 years old: 1. Respiratory symptoms, such as cough, shortness of breath, and activity intolerance. 2. Physical sign, such as shortness of breath at rest, rales
Index test:Transbronchial cryobiopsy

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old, male or female; (2) Those who are suspected as chILD according to the diagnostic criteria for chILD; (3) Low-flowing oxygen intake arterial oxygen partial pressure > 60mmHg; (4) High-resolution CT of the chest shows unexplained diffuse lesions of both lungs, and the main lesions are located in the distal bronchial lung tissue or peripheral lung lesions below the bronchi of both lung segments; (5) The diagnosis cannot be confirmed by laboratory examinations, imaging examinations or routine bronchoscopy; (6) Cardiopulmonary function can tolerate general anesthesia, coagulation function is normal; (7) Voluntarily participate and the child's legal guardian signs the informed consent form. The process of obtaining informed consent complies with GCP regulations.

Exclusion criteria

Exclusion criteria: (1) Those who have contraindications to pediatric bronchoscopy and cannot be corrected; (2) Those who have poor compliance and cannot complete this study; (3) Those who are participating in clinical trials or have participated in other clinical trials in the past three months; (4) Those who are not suitable to participate considered by investigators in this clinical study.

Design outcomes

Primary

MeasureTime frame
Clinical manifestations and concomitant diseases;radiological data;Bronchoscopy and transbronchial biopsy;Indicators for bronchoalveolar lavage fluid;Size and quality of specimens;Diagnostic performance of specimens;Efficiency of pathological diagnosis;Incidence and severity of complications;Accuracy of pathological diagnosis ;Specificity of pathological diagnosis ;Sensitivity of pathological diagnosis;

Secondary

MeasureTime frame
Demographic information;Current and past medical history;History of growth and development;Family health history;Clinical treatment and therapeutic effect;Lab test results;Pulmonary function tests;Surgical procedures;Genetic screening;

Countries

China

Contacts

Public ContactLeping Ye

Peking University First Hospital

yeleping@bjmu.edu.cn+86 158 0108 6782

Outcome results

None listed

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