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Status unknownNCT03958162Updated May 21, 2019

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

An interventional study of lung biopsy in Surgical Lung Biopsy, Transbronchial Lung Cryobiopsy and Interstitial Lung Disease, sponsored by Guangzhou Institute of Respiratory Disease. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-21.

Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Surgical Lung Biopsy
  • Transbronchial Lung Cryobiopsy
  • Interstitial Lung Disease

Keywords

  • surgical lung biopsy
  • transbronchial lung cryobiopsy
  • interstitial lung disease
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    uniportal and tubeless video assisted thoracic surgery

    lung biospy by the uniportal and tubeless video assisted thoracic surgery

    Diagnostic Test: lung biopsy

  • Experimental
    transbronchial lung cryobiopsy

    transbronchial lung cryobiopsy

    Diagnostic Test: lung biopsy

Interventions

  • Diagnostic testlung biopsy

    transbronchial lung cryobiopsy

06

What researchers measure

Primary outcomes

  1. Diagnotic yield

    Percentage of definitive diagnosis within the multidisciplinary discussion context by two different biopsy methods

    Time frame: two weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03958162
Lead sponsor
Guangzhou Institute of Respiratory Disease
Responsible party
ShiYue Li (Director of the Respiratory department, Guangzhou Institute of Respiratory Disease) — Principal investigator
First posted
May 21, 2019
Start date
Jun 1, 2019 (estimated)
Primary completion
Jun 1, 2020 (estimated)
Completion
Jun 1, 2020 (estimated)
Last update
May 21, 2019

Study contacts

Xiaobo Chen, Doctor
Contact
xiaobo-win@163.com
+8613751721744

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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