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

NCT ID: NCT03958162

Last Updated: 2019-05-21

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

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-06-01

Brief Summary

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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

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Conditions

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Surgical Lung Biopsy Transbronchial Lung Cryobiopsy Interstitial Lung Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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uniportal and tubeless video assisted thoracic surgery

lung biospy by the uniportal and tubeless video assisted thoracic surgery

Group Type EXPERIMENTAL

lung biopsy

Intervention Type DIAGNOSTIC_TEST

transbronchial lung cryobiopsy

transbronchial lung cryobiopsy

transbronchial lung cryobiopsy

Group Type EXPERIMENTAL

lung biopsy

Intervention Type DIAGNOSTIC_TEST

transbronchial lung cryobiopsy

Interventions

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lung biopsy

transbronchial lung cryobiopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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ShiYue Li

Director of the Respiratory department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Xiaobo Chen, Doctor

Role: CONTACT

+8613751721744

Other Identifiers

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TS20181008

Identifier Type: -

Identifier Source: org_study_id

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