Cone Beam CT Guided Transbronchial Cryobiopsy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CBCT guided TBCB Patients with ILD who met the following including criteria from September 2018 to July 2019 were suggested to receive TBCB under CBCT guidance: 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%, patients without acute exacerbation within one month, patients without bleeding diathesis, anticoagulant therapy, using antiplatelet drugs, patients without pulmonary hypertension, respiratory failure, liver or kidney disfunction, or cardiac insufficiency, PLT more than 50 x 109/L. All included patients signed the informed consent. |
Procedure: cone beam CT guided transbronchial cryobiopsy
CBCT images are acquried and reviewed in axial, coronal and sagittal planes to most accurately assess the cryoprobe position within the lung parenchyma and relative to other thoracic structures. The minimum probe-to-pleura distance will be measured. If the position of cryoprobe is proper, TBCB will be perfomed.
|
Outcome Measures
Primary Outcome Measures
- safety profile of procedure [30 days]
pneumothorax, bleeding severity, post-bronchoscopy fever, acute exacerbation of ILD, procedure related death.
Secondary Outcome Measures
- diagnostic efficacy [30 days]
diagnostic yield
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China-Japan Friendship Hospital | Beijing | Beijing | China | 100029 |
Sponsors and Collaborators
- China-Japan Friendship Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChinaJapanFH004