Alveoscopy, Endoscopic Confocal Microscopy and Lung Rejection, Parenchymal Lung Diseases in Vivo

Mayo Clinic

Status: Completed

Conditions: Lung Transplant

Treatments: Other: Confocal imaging

Study type: Observational

Funder types: Other

Identifiers

NCT01033201

08-000800

ACA00001534

Details and patient eligibility

About

Lung transplantation is indicated when end-stage lung diseases no longer respond to available standard therapy, making life expectancy short and associated with disability. Acute and chronic rejection are common complications following transplantation, indicating screening bronchoscopies and transbronchial biopsies at three month intervals the first two years, in addition to clinically indicated procedures when rejection or infection is suspected. Transbronchial biopsies carry associated risks (bleeding, pneumothorax). Chronic rejection is characterized by progressive obliteration of distal airways (Bronchiolitis Obliterans-BO-). BO requires open lung biopsy for diagnosis. Alternatively, a clinical surrogate (Bronchiolitis Obliterans Syndrome), characterized by decline in Forced Expired Volume in 1 second not explained by acute rejection or infection is used for diagnosis. The new technique of confocal endo-microscopy enables sub-surface visualization of tissue in vivo during bronchoscopic procedures using a probe-based confocal microscope, integrated to a standard endoscope. Bronchiolar and alveolar structures can be visualized at a cellular and nuclear level, and these images can be saved and reviewed. This new technology could potentially identify acute and chronic rejection, thus offering and alternative to transbronchial biopsies. We expect to describe a new alternative to diagnose acute and chronic rejection using confocal microscopy images obtained endoscopically, obviating complications of transbronchial biopsies.

Endoscopic confocal endomicroscopy can detect and classify common bronchiolar and alveolar pathological conditions in real time. Specifically, we hypothesize that confocal endomicroscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help to recognize and classify the presence/absence of acute rejection and/or bronchiolitis obliterans syndrome in lung transplant recipients. This technology could also identify the histological characteristics lung diseases such as interstitial, obstructive or vascular end stage lung diseases, and thus lead to more efficient, safer and more accurate diagnosis of these lung conditions during routine bronchoscopies.

Enrollment: 71 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age above 18 years
2. Any patient undergoing surveillance or clinically indicated bronchoscopies during or after lung transplantation
3. Any patient undergoing bronchoscopy prior lung transplant

Exclusion criteria

1. Unwilling to consent
2. Unable to safely tolerate a bronchoscopic procedure

Trial design

71 participants in 1 patient group

Lung transplant

Description:

All lung transplant patients presenting for screening/surveillance and diagnostic bronchoscopies at Mayo Clinic Florida are eligible for participation.

Treatment:

Other: Confocal imaging