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Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases
Study Purpose
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.#46;a longer freezing time and less number of biopsies.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- Inpatients with suspected ILD based on clinical and radiological features.
- Male or female patients aged ≥18 years.
- Signed the informed consent.
- Clinical indication to performed a lung biopsy in radiologically proven ILD.
Exclusion Criteria:
- Bleeding risk:
- Known predisposition to bleeding.
- International randomised ratio (INR) >1,5,
- Elevated partial thromboplastin time (PTT)
- Platelet count < 80000/ul.
- Patients who required full-dose therapeutic anticoagulation or clopidogrel or
other thienopyridines.
- Oxygen saturation < 90% with supported Oxygen 2l/min.
- Severe bullous pulmonary emphysema.
- Severe cardiac disease (angina pectoris, acute myocardial infarction in the last 6
month, acute hearth failure)
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
N/A
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
University Hospital, Essen
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Kaid Darwiche
Principal Investigator Affiliation
Head of department of inteventionel pneumology, Ruhrlandklinik Essen
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Other
Overall Status
Recruiting
Countries
Germany
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Interstitial Lung Disease
Additional Details
Design:
The investigators design a prospective randomised multicenter study to assess the diagnostic
value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia by comparing
two different interventional methods.
Patients with suspected ILD in which the clinical, radiological and BAL-data are insufficient
to establish a definitive clinical diagnosis, requiring then tissue specimen to determine a
diagnosis would be included.
Therefore this all patients will undergo transbronchial cryobiopsy. If a definitive diagnosis
even after cryobiopsy and MDD cannot be made, SLB will be recommended.
For the cryobiopsies the 1.9 mm cryoprobe and ERBECRYO®2 with carbon dioxide will be used.
All transbronchial cryobiopsies have to be obtained of one or two lobes of the same lung and
in at least two different segments. The bronchopulmonary segment for the cryobiopsy will be
selected based on the radiological features shown on a high resolution computed tomography
(HRCT) of the chest. The areas with exclusively fibrotic changes should be avoided. After
having touched the pleura with the cryopobe, the probe is retracted one to two centimetres
and then in this position the freezing process will be initiated. The flexible bronchoscope
with the inserted cryoprobe will be removed through the rigid bronchoscope after the sample
was obtained.
The cryobiopsies can be performed in rigid or flexible bronchoscopy. The use of a Fogarty
occlusion balloon is left to the discretion of the bronchoscopist.
Experimental Groups:
Group nº1: A total of 3 samples with a freezing time of 7 seconds at least for the first
biopsy and a freezing time from ≥5 seconds for the following biopsies.
Group nº 2: A total of 8 samples with a freezing time of 3 seconds at least for the first
biopsy and a freezing time from <5 seconds for the following biopsies.
Patient preselection:
Inclusion criteria. 1. Inpatients with suspected ILD based on clinical and radiological features. 2. Inpatients with probable pulmonary sarcoidosis without hilar or mediastinal lymph node
enlargement. 3. Male or female patients aged ≥18 years. 4. Signed the informed consent. Exclusion criteria. 1. Bleeding risk:
1. Known predisposition to bleeding. 2. International randomised ratio (INR) >1,5,
3. Elevated partial thromboplastin time (PTT)
4. Platelet count < 80000/ul)
5. Patients who required full-dose therapeutic anticoagulation or double antiplatelet
therapy which can not be stopped as recommended before the cryobiopsy. 2. Oxygen saturation < 90% with supported Oxygen 2l/min. 3. Diffusing capacity (DLCO) <35% or FVC< 50%
4. Significant pulmonary emphysema. 5. Severe cardiac disease (angina pectoris, acute myocardial infarction in the last 6
month, acute hearth failure)
6. Documented pulmonary hypertension PAP sys >50mmHg. 7. Typical UIP-Pattern in HRCT. Patient's recruitment:
The recruited patients who present all characteristics of the inclusion criteria and none of
the exclusion criteria and who signed the inform consent undergo cryobiopsy. All patients
undergo a clinical evaluation.
After the clinical evaluation a MDD will take place. In the first MDD a provisional clinical
diagnose is proposed. If a transbronchial cryobiopsy is indicated by the MDD, patients are
randomised to the groups 1 or 2 immediate before the bronchoscopy.
Once the histological result is achieved, another MDD including the pathologist for
establishing the definitive clinical diagnose take place. As all local pathologists of the
participating centres are experienced in ILD, the samples are evaluated by the respective
pathologist. If case of uncertainty, the samples can be evaluated by a second pathologist in
one of the participating centres.
Arms & Interventions
Arms
Experimental: Cryobiopsy: longer freezing time
Group nº1: A total of 3 samples with a freezing time of 7 seconds at least for the first biopsy and a freezing time from ≥5 seconds for the following biopsies.
Experimental: Cryobiopsy: shorter freezing time
Group nº 2: A total of 8 samples with a freezing time of 3 seconds at least for the first biopsy and a freezing time from <5 seconds for the following biopsies.
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
Contact a Trial Team
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