Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.

Interstitial Lung Disease Clinical Trial

— TRABIS  

Official title:

Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894113
• Other study ID #: TBB2010
• Status: Completed
• Phase: N/A
• First received: July 2, 2013
• Last updated: May 2, 2015
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• transbronchial lung biopsy

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery)		24 months	Yes
Primary	Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.		24 months	No
Secondary	Differences in the final diagnosis		24 Months	No