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

Not Applicable

• Conditions: Surgical Lung Biopsy; Transbronchial Lung Cryobiopsy; Interstitial Lung Disease
• Interventions: Diagnostic Test: lung biopsy

• Registration Number: NCT03958162
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Last Update Submitted: 2019-05-20
• Study First Posted: 2019-05-21
• Last Update Posted: 2019-05-21
• Study Start: 2019-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transbronchial lung cryobiopsy	lung biopsy	transbronchial lung cryobiopsy
uniportal and tubeless video assisted thoracic surgery	lung biopsy	lung biospy by the uniportal and tubeless video assisted thoracic surgery

Primary Outcome Measures

Name	Time	Method
Diagnotic yield	two weeks	Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods