Clinical trial NCT01894113: Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.
Official title: Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: interstitial lung disease
transbronchial biopsy
cryobiopsy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease

Detailed description: Endoscopic biopsy currently plays only a minor role for the diagnosis of interstitial lung disease. However, in some cases obtaining lung tissue is necessary to establish a final diagnosis. The current standard procedure is transbronchial forceps biopsy - if not sufficient: surgical lung biopsy. Transbronchial lung biopsy bears essential limitations however:

* Small tissue sample
* Limited evaluability of the material caused by forceps-induced crush artifacts

In cryobiopsy the cryoprobe´s tip is being cooled and thereby cools the surrounding tissue to approximately minus 89 degrees Celsius. Subsequently, the frozen probe is retracted with the frozen tissue being attached onto the frozen probe's tip. When applied in the central airways, cryobiopsy proved to deliver large specimens of good quality, which may exceed forceps biopsies in terms of diagnostic yield. Pilot studies on transbronchial cryobiopsy showed that same advantages as seen in the endobronchial use.

Eligibility criteria: Inclusion Criteria:

1. Clinical indications for biopsy of interstitial lung disease
2. Age over 18 years
3. Signed consent

Exclusion Criteria:

1. Risk of bleeding / ongoing anticoagulation
2. Oxygen saturation \<90% - despite delivery of 2l oxygen / min
3. Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure)
4. Pulmonary hypertension, PAP sys\> 50mmHg

Primary outcomes:
measure: Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
timeFrame: 24 months
Secondary outcomes:
measure: Differences in the final diagnosis
timeFrame: 24 Months
Other outcomes:
measure: Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery)
timeFrame: 24 months
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Jürgen Hetzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hetzel J, Eberhardt R, Petermann C, Gesierich W, Darwiche K, Hagmeyer L, Muche R, Kreuter M, Lewis R, Ehab A, Boeckeler M, Haentschel M. Bleeding risk of transbronchial cryobiopsy compared to transbronchial forceps biopsy in interstitial lung disease - a prospective, randomized, multicentre cross-over trial. Respir Res. 2019 Jul 5;20(1):140. doi: 10.1186/s12931-019-1091-1.