LUNG COOL TRIAL
Research type
Research Study
Full title
LUNG COOL trial - CryOextractiOn of Lung tissue for diagnosis of interstitial LUNG diseases
IRAS ID
182874
Contact name
Joanna Porter
Contact email
Sponsor organisation
UCL
Duration of Study in the UK
2 years, 6 months, 3 days
Research summary
Interstitial Lung Diseases (ILDs) are a group of diseases that cause variably progressive lung fibrosis and considerable morbidity and mortality. Frequently the identification of the ILD subtype can be made from the patient’s history, examination, blood results and radiological findings; however in some cases the underlying disease pattern remains obscure. For these reasons a proportion of patients are recommended to undergo a surgical lung biopsy (SLB) to gain additional histopathological information. Precise diagnosis is important as it allows us to predict prognosis and target treatment more accurately.
Advances in bronchsocopy mean that we may be able to obtain diagnostic biopsies in a minimally invasive way. We believe that adequate lung biopsies can be taken through a bronchoscope using a cryoprobe. This has been shown to be safe in previous studies and the procedure is well established in a number of European centres. UCLH has introduced the technique in 2014.
If we can show that transbronchial cryoscopic lung biopsy (TBCLB) can establish a firm pathological diagnosis then fewer patients will need to undergo SLB, which is associated with significant mortality of 2-4% and complications in up to 28%. SLB is associated with significant health expenditure. In 2012, 910 SLB were performed in the UK for suspected ILD and with an average hospital stay of 3.5 days this amounts to 8.7 patient years spent in hospital.
By contrast TBCLB is a minimally invasive day case procedure which offers considerable financial savings over SLB. In addition it could be available to patients who are not fit to undergo surgery therefore improving their care through accurate diagnosis.
The ultimate aim of this study is to prove that TBCLB can largely replace SLB and thereby significantly reduce cost and improve patients’ experience.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/0454
Date of REC Opinion
14 Apr 2016
REC opinion
Further Information Favourable Opinion