Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease. (TRABIS)
Primary Purpose
Interstitial Lung Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
transbronchial lung biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Interstitial Lung Disease focused on measuring interstitial lung disease, transbronchial biopsy, cryobiopsy
Eligibility Criteria
Inclusion Criteria:
- Clinical indications for biopsy of interstitial lung disease
- Age over 18 years
- Signed consent
Exclusion Criteria:
- 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
Sites / Locations
- University Hospital Tuebingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
transbronchial forceps lung biopsy
transbronchail cryo lung biopsy
Arm Description
transbronchial lung biopsy forceps
transbronchial lungbiopsy with cryoprobe
Outcomes
Primary Outcome Measures
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
Secondary Outcome Measures
Differences in the final diagnosis
Full Information
NCT ID
NCT01894113
First Posted
July 2, 2013
Last Updated
May 2, 2015
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT01894113
Brief Title
Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.
Acronym
TRABIS
Official Title
Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
interstitial lung disease, transbronchial biopsy, cryobiopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
382 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transbronchial forceps lung biopsy
Arm Type
Active Comparator
Arm Description
transbronchial lung biopsy forceps
Arm Title
transbronchail cryo lung biopsy
Arm Type
Active Comparator
Arm Description
transbronchial lungbiopsy with cryoprobe
Intervention Type
Procedure
Intervention Name(s)
transbronchial lung biopsy
Primary Outcome Measure Information:
Title
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Differences in the final diagnosis
Time Frame
24 Months
Other Pre-specified Outcome Measures:
Title
Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical indications for biopsy of interstitial lung disease
Age over 18 years
Signed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Hetzel, MD
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tuebingen
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
31277659
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.
Results Reference
derived
Learn more about this trial
Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.
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