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

May 20, 2019 updated by: ShiYue Li, Guangzhou Institute of Respiratory Disease

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: uniportal and tubeless video assisted thoracic surgery
lung biospy by the uniportal and tubeless video assisted thoracic surgery
Diagnostic test: lung biopsy
transbronchial lung cryobiopsy
Experimental: transbronchial lung cryobiopsy
Diagnostic test: lung biopsy
transbronchial lung cryobiopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnotic yield
Time Frame: two weeks
Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS20181008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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