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The Comparison of Uniportal and Tubeless Video Assisted Thoracic Surgery and Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease

Study Purpose

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 disease,and assess the safety and cost-effectiveness. This is a prospective control trial.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03958162
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Guangzhou Institute of Respiratory Disease
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Surgical Lung Biopsy, Transbronchial Lung Cryobiopsy, Interstitial Lung Disease
Arms & Interventions

Arms

Experimental: uniportal and tubeless video assisted thoracic surgery

lung biospy by the uniportal and tubeless video assisted thoracic surgery

Experimental: transbronchial lung cryobiopsy

transbronchial lung cryobiopsy

Interventions

Diagnostic Test: - lung biopsy

transbronchial lung cryobiopsy

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Xiaobo Chen, Doctor

xiaobo-win@163.com

+8613751721744

For additional contact information, you can also visit the trial on clinicaltrials.gov.