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

NCT04285463 | Completed

• 1 other identifier: 19.280
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Determine the probe size that yield the best lung biopsy specimens for histological analysis in an ex-vivo human model.

  Multiple Transbronchial Lung Cryobiopsies (TBLCs) will be taken from the lungs using different probe sizes: 1.9 and 2.4 milimeters . The size and quality of the lung tissue samples will be compared to analyze which settings are optimal for obtaining the best quality specimens.

  Time of procedure

• Determine the freezing probe time that yield the best lung biopsy specimens for histological analysis in an ex-vivo human model.

  Multiple Transbronchial Lung Cryobiopsies (TBLCs) will be taken from the lungs and during the procedure each probe (1.9 and 2.4 milimiters) will be activated with different freezing times: first with 30 seconds followed by 20 seconds, then 10 seconds, 5 seconds and 3 seconds, successively. The size and quality of the lung tissue samples will be compared to analyze which settings are optimal for obtaining the best quality specimens.

  Time of procedure

• Determine the distance from tip of the probe to the pleura that yield the best lung biopsy specimens for histological analysis in an ex-vivo human model.

  Multiple Transbronchial Lung Cryobiopsies (TBLCs) will be taken from the lungs and during the procedure each probe (1.9 and 2.4 milimiters) will be activated at different distances from the pleura Inside the bronchus: first 5 milimeters apart, then 10 milimeters and 20 milimeters, successively.

  Time of procedure

Interventions

Transbronchial Lung Cryobiopsy (TBLC) DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation.

You may not qualify if:

• Patients not candidates for surgical removal of the lungs during the act of transplantation.

Sponsors & Collaborators

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

Study Sites (1)

CHUM

Montreal, Quéebec, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thoracic Surgeon Principal Investigator

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 26, 2020
• Study Start: March 4, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)