Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases
NCT03727568 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2022-11-02
Summary
Interstitial lung diseases (ILD) are a heterogeneous collection of more than 100 different pulmonary disorders. Surgical lung biopsie in combination with multidisciplinary discussion is recommend in combination to reach a consensus diagnosis when the initial clinical evaluation is inconclusive in the diagnosis of ILD. Cryobiopsy via bronchoscopy is approved for lung biopsies and allows harvesting of large tissue samples of excellent. This technique is not jet standardized. In this prospective randomised study the investigators want to evaluate the diagnostic yield comparing two different techniques of performing transbronchial cryobiopsy. In this study would be compared a shorter freezing time and more number of biopsies vs a longer freezing time and less number of biopsies.
Conditions
Interventions
- PROCEDURE
-
Cryobiopsy
In this study the investigators want to evaluate the diagnostic yield comparing 2 different techniques of performing cryobiopsy. A shorter freezing time and more number of biopsies vs a longer freezing time and less number of biopsies would be compared. Patients are randomised to the groups 1 or 2 immediate before the bronchoscopy. Group 1: a total of 3 samples with a freezing time of 7 seconds at least for the first biopsy and freezing time for 5 seconds or more for the followings biopsies Group 2: a total of 8 samples with a freezing time of 3 seconds at least for the first biopsy and freezing time for less than 5 seconds for the followings biopsies
Sponsors & Collaborators
-
Marta Cuyás
collaborator UNKNOWN -
University Hospital, Essen
lead OTHER
Principal Investigators
-
Kaid Darwiche · Head of department of inteventionel pneumology, Ruhrlandklinik Essen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-11
- Primary Completion
- 2022-05-11
- Completion
- 2022-12-31
Countries
- Germany
Study Locations
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