Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727568
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Marta Cuyás
Information provided by (Responsible Party):
Kaid Darwiche, University Hospital, Essen

Brief 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.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Procedure: Cryobiopsy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Prospective, Randomised Study Comparing Two Different Methods of Transbronchial Cryobiopsy in the Interstitial Lung Diseases
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : October 11, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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


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.
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





Primary Outcome Measures :
  1. Diagnostic yield [ Time Frame: 2 years ]
    The investigator will assess the proportion of patients in which a definitive diagnosis is possible after Multi-Disciplinary Discussion


Secondary Outcome Measures :
  1. Complications [ Time Frame: 2 years ]
    Number of pneumothorax, bleeding and acute exacerbation.

  2. Number of diagnostic samples [ Time Frame: 2 years ]
  3. Correlation between the suspected clinical diagnosis and the histological diagnosis [ Time Frame: 2 years ]
  4. Correlation between between radiological pattern and final diagnosis [ Time Frame: 2 years ]
    The investigator want to evaluate the patient rate in which the radiological pattern could be confirmed by histological finding



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727568


Contacts
Layout table for location contacts
Contact: Marta Cuyás 0049 201 4330 marta.cuyas@rlk.uk-essen.de
Contact: Kaid Darwiche 0049 201 4330

Locations
Layout table for location information
Germany
Ruhrlandklinik Recruiting
Essen, NRW, Germany, 45239
Contact: Marta Cuyas, MD    004920143301      
Contact: Kaid Darwiche, MD    004920143301      
Sponsors and Collaborators
University Hospital, Essen
Marta Cuyás
Investigators
Layout table for investigator information
Principal Investigator: Kaid Darwiche Head of department of inteventionel pneumology, Ruhrlandklinik Essen

Layout table for additonal information
Responsible Party: Kaid Darwiche, PD Dr. med Kaid Darwiche, Head Department of Interventional Pneumology, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT03727568     History of Changes
Other Study ID Numbers: RLK-Kryo-1
18-7951-BO ( Registry Identifier: Ethical Review Board University Clinic Essen )
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases