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Defining Optimal Settings for Transbronchial Lung Cryobiopsy II: An Ex-Vivo Human Lungs Model Study for Improvement of Specimen Quality

NCT04285463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-03-27

No results posted yet for this study

Summary

Diffuse parenchymal lung disease (DPLD) or Interstitial Lung Disease (ILD) comprises a broad variety of lung pathologies in which accurate diagnosis is crucial given to the different prognosis and therapeutic approaches, especially with the advent of new antifibrotic therapies.

Histology is an important tool when radiologic findings, clinical manifestations and bronchoalveolar lavage analysis are inconclusive. Surgical lung biopsy (SLB) is the gold standard for tissue sampling/analysis, however there is an associated cost and risk with a mortality-related between 1.8 and 3.6% for elective cases and up to 16% for the non-elective ones.

Transbronchial lung cryobiopsy (TBLC) is a safe, well-established technique used to obtain lung biopsies with large, high-quality specimens using compressed gas to freeze the tissue. The larger fragments do not contain the same crush artifacts seen in conventional transbronchial biopsies (TBB), but the non-standardization of the technique could be a limitation to the quality of the specimens and its safety.

The objective of this project is to determine the optimal settings for TBLC in human lungs with ILD in order to obtain the best quality specimens with the lowest risk profile. Two previous studies using animal models evaluated the technical components, such as probe size, freezing time and probe to pleura distance that results in good quality specimens. However, these were in normal animal lungs without ILD. In this new project, multiple TBLCs will be taken from lungs of documented ILD patients undergoing lung transplantation after their removal from the recipient patient at the time of lung transplantation.

Conditions

  • Transbronchial Lung Cryobiopsy

Interventions

DIAGNOSTIC_TEST

Transbronchial Lung Cryobiopsy (TBLC)

TBLC is a relatively new endoscopic technique used to obtain lung parenchyma specimens. It is a minimally invasive technique performed with a flexible or rigid bronchoscope under deep sedation or general anesthesia. Flexible cryoprobes of either 1.9 or 2.4 mm in diameter are introduced into a bronchoscope and a compressed gas, most commonly carbon dioxide or nitrous oxide, is released at high flow at the tip of the probe. As the tissue rapidly freezes, it adheres to the probe and is avulsed and extracted with a quick pullback movement followed by immediate extraction of samples.

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2021-07-17
Completion
2021-07-17

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285463 on ClinicalTrials.gov