ILD Clinical Trial
Official title:
The Safety and Diagnostic Efficacy of Cone Beam CT Guided Transbronchial Cryobiopsy for ILD Patients
Verified date | August 2019 |
Source | China-Japan Friendship Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Interstitial lung diseases (ILD) are common in clinical practices and need multidisciplinary
assessment of clinical presentations, radiological and histological features. Transbronchial
cryobiopsy (TBCB) is one of the most important invasive procedures for ILD when a confident
diagnosis cannot be made by clinical and radiological assessment. TBCB could lead to higher
incidence of risks. The pneumothorax and severe bleeding seemed to be more common in patients
with TBCB.
Cone-beam computed tomography (CBCT) could provide 3-dimensinal (3D) CT images which were
close to the image qualities of conventional CT. The probe-to-pleura relationship could be
accurately established by the 3D CT scan and the cryobiopsy safety profile might be improved
under the guidance of CBCT. In this study, we conducted a prospective study to observe the
safety and diagnostic efficacy of CBCT guided TBCB for the DPLD patients.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - more than 18 years old, diffuse parenchymal lung diseases without a diagnosis after integration of clinical profile, laboratory tests and HRCT features, FVC more than 50%, DLCO more than 35% Exclusion Criteria: - acute exacerbation within one month, bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients with pulmonary hypertension, respiratory failure, liver, kidney disfunction, and cardiac insufficiency, PLT less than 50 x 109/L |
Country | Name | City | State |
---|---|---|---|
China | China-Japan Friendship Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China-Japan Friendship Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | safety profile of procedure | pneumothorax, bleeding severity, post-bronchoscopy fever, acute exacerbation of ILD, procedure related death. | 30 days | |
Secondary | diagnostic efficacy | diagnostic yield | 30 days |
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