Cone Beam CT Guided Transbronchial Cryobiopsy

• Conditions: ILD
• Interventions: Procedure: cone beam CT guided transbronchial cryobiopsy

• Registration Number: NCT04047667
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-04
• Study First Submitted QC: 2019-08-04
• Last Update Submitted: 2019-08-04
• Study First Posted: 2019-08-07
• Last Update Posted: 2019-08-07
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CBCT guided TBCB	cone beam CT guided transbronchial cryobiopsy	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.

Primary Outcome Measures

Name	Time	Method
safety profile of procedure	30 days	pneumothorax, bleeding severity, post-bronchoscopy fever, acute exacerbation of ILD, procedure related death.

Secondary Outcome Measures

Name	Time	Method
diagnostic efficacy	30 days	diagnostic yield

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China