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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03958162
Other study ID # TS20181008
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date June 1, 2020

Study information

Verified date May 2019
Source Guangzhou Institute of Respiratory Disease
Contact Xiaobo Chen, Doctor
Phone +8613751721744
Email xiaobo-win@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compariing the uniportal and tubeless video assisted thoracic surgery and trnsbronchial lung cryobiopsy within the multidisciplinary discussion context in the diagnosis of interstitial lung diseaseļ¼Œand assess the safety and cost-effectiveness. This is a prospective control trial.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. 18 yrs = age<75yrs

2. Patients diagnosed as interstitial lung disease with comprehensive clinical data (including history, serological test, spirometry test and high resolution computed tomography)

3. Further pathological data was still required after multidisciplinary discussion.

Exclusion Criteria:

1. Severe pulmonary dysfunction: forced vital capacity (FVC) =65% or carbon-monoxide diffusion coefficient (DLco) =45% of predicted value

2. Pulmonary hypertension: An estimated systolic pulmonary artery pressure>50mmHg on echocardiography

3. Abnormal coagulation parameters or thrombocytopenia (<50*109/L)

4. Severe comorbidities leading to inoperable condition

5. Patients cannot give consent or refuse biopsy

Study Design


Intervention

Diagnostic Test:
lung biopsy
transbronchial lung cryobiopsy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Institute of Respiratory Disease

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnotic yield Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods two weeks
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