Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.
TRABIS
1 other identifier
interventional
382
1 country
1
Brief Summary
The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 2, 2013
CompletedFirst Posted
Study publicly available on registry
July 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 5, 2015
May 1, 2015
2.3 years
July 2, 2013
May 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
24 months
Secondary Outcomes (1)
Differences in the final diagnosis
24 Months
Other Outcomes (1)
Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery)
24 months
Study Arms (2)
transbronchial forceps lung biopsy
ACTIVE COMPARATORtransbronchial lung biopsy forceps
transbronchail cryo lung biopsy
ACTIVE COMPARATORtransbronchial lungbiopsy with cryoprobe
Interventions
Eligibility Criteria
You may qualify if:
- Clinical indications for biopsy of interstitial lung disease
- Age over 18 years
- Signed consent
You may not qualify if:
- Risk of bleeding / ongoing anticoagulation
- Oxygen saturation \<90% - despite delivery of 2l oxygen / min
- Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure)
- Pulmonary hypertension, PAP sys\> 50mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tuebingen
Tübingen, Germany
Related Publications (1)
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.
PMID: 31277659DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jürgen Hetzel, MD
University Hospital Tuebingen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Michael Böckeler
Study Record Dates
First Submitted
July 2, 2013
First Posted
July 9, 2013
Study Start
January 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 5, 2015
Record last verified: 2015-05