Cone Beam CT Guided Transbronchial Cryobiopsy

NCT ID: NCT04047667

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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ILD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

cone beam CT guided transbronchial cryobiopsy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dai Huaping

vice Director of Respiratory disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Huaping Dai, MD

Role: primary

0086-13901293597

Guowu Zhou, MD

Role: backup

0086-13585939427

References

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Bian Y, Deng M, Gao Q, Zhou G, Tong R, Zhao L, Liu M, Sun J, Dai H, Herth FJF, Hou G, Wang C. The Diagnostic Efficiency and Safety of Transbronchial Lung Cryobiopsy Using 1.1-mm Cryoprobe in Diagnosing Interstitial Lung Disease. Lung. 2024 Oct;202(5):615-623. doi: 10.1007/s00408-024-00713-2. Epub 2024 Jun 23.

Reference Type DERIVED
PMID: 38910197 (View on PubMed)

Bian Y, Zhou G, Gao Q, Deng M, Tong R, Xia Y, Lin J, Hou G, Dai H. Assessment of a randomized controlled trial on the safety of pre-placing bronchial balloons in transbronchial lung cryobiopsy for diagnosing interstitial lung disease. Eur J Med Res. 2024 May 3;29(1):268. doi: 10.1186/s40001-024-01871-y.

Reference Type DERIVED
PMID: 38702744 (View on PubMed)

Other Identifiers

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ChinaJapanFH004

Identifier Type: -

Identifier Source: org_study_id

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