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The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases

The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03704233
Enrollment
350
Registered
2018-10-12
Start date
2018-11-01
Completion date
2021-10-20
Last updated
2019-03-07

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

Conditions

Diffuse Parenchymal Lung Diseases

Keywords

Transbrochial cryobiopsy, Diffuse parenchymal lung diseases, Diagnosis

Brief summary

The Diagnostic yield and Safety of transbronchial cryobiopsy in the diagnosis of diffuse parenchymal lung diseases are investigated in this multicenter, prospective and real world study.

Interventions

Transbronchial cryobiopsy procedure

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data. 2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. 3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.

Exclusion criteria

1. The radiological data indicates non-DPLD 2. The clinical examinations mentioned above are not completed. 3. The patient cannot endure or does not agree the procedure.

Design outcomes

Primary

MeasureTime frameDescription
Diagnotic yieldtwo weeksPercentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy

Secondary

MeasureTime frameDescription
Complication rate12 weeksIncidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy (in 12 weeks).

Countries

China

Contacts

Primary ContactShiyue Li
lishiyue@188.com8620-83062896
Backup ContactXiaobo Chen
xiaobo-win@163.com8620-83062885

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026