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Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease

Primary Purpose

Interstitial Lung Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lung biopsy
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interstitial Lung Disease focused on measuring Cryobiopsy, lung biopsy, interstitial lung disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • IIP suspected on clinical and radiologic grounds

Exclusion Criteria:

  • Age >80y and <18y
  • FVC< 55%, DCO<35%
  • Platelet count <100000/µl
  • acetylsalicylic acid, clopidogrel or equivalent during the last 5 days
  • INR > l,3,
  • elevated PTT (> 40 s)
  • documented pulmonary hypertension PAPS >50mmHg
  • HR-CT highly suspicious for sarcoidosis

Sites / Locations

  • RuhrlandklinikRecruiting
  • ThoraxklinikRecruiting
  • University Hospital TuebingenRecruiting
  • Ospedale G.B. MorgagniRecruiting
  • Respiratory Department Hospital of Santa Creu i Sant PauRecruiting
  • Royal Brompton HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung biopsy

Arm Description

assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS

Outcomes

Primary Outcome Measures

Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy

Secondary Outcome Measures

numer of bleeding events
Rate of pneumothoraxes
numer of exacerbations after biopsy
Contribution of BAL and cryobiopsy to diagnosis
Size of specimen
Quality of specimen
Distribution of histological changes in the specimen
Influence of the size of the cryoprobe in the primary endpoint
Comparative group (out of trial) - who are referred for VATS directly ['positive control group']
Rate of exacerbations after cryobiopsy and after surgical biopsy

Full Information

First Posted
May 2, 2015
Last Updated
October 25, 2016
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02563730
Brief Title
Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Official Title
Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

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
A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
Cryobiopsy, lung biopsy, interstitial lung disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lung biopsy
Arm Type
Experimental
Arm Description
assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS
Intervention Type
Procedure
Intervention Name(s)
Lung biopsy
Intervention Description
transbronchial lung biopsy. First kryobiopsy, second open biopsy
Primary Outcome Measure Information:
Title
Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
numer of bleeding events
Time Frame
1 day
Title
Rate of pneumothoraxes
Time Frame
1 day
Title
numer of exacerbations after biopsy
Time Frame
6 weeks
Title
Contribution of BAL and cryobiopsy to diagnosis
Time Frame
2 weeks
Title
Size of specimen
Time Frame
2 weeks
Title
Quality of specimen
Time Frame
2 weeks
Title
Distribution of histological changes in the specimen
Time Frame
2 weeks
Title
Influence of the size of the cryoprobe in the primary endpoint
Time Frame
2 weeks
Title
Comparative group (out of trial) - who are referred for VATS directly ['positive control group']
Time Frame
6 weeks
Title
Rate of exacerbations after cryobiopsy and after surgical biopsy
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IIP suspected on clinical and radiologic grounds Exclusion Criteria: Age >80y and <18y FVC< 55%, DCO<35% Platelet count <100000/µl acetylsalicylic acid, clopidogrel or equivalent during the last 5 days INR > l,3, elevated PTT (> 40 s) documented pulmonary hypertension PAPS >50mmHg HR-CT highly suspicious for sarcoidosis
Facility Information:
Facility Name
Ruhrlandklinik
City
Essen
ZIP/Postal Code
45239
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Costabel
Phone
0201-433-4021
First Name & Middle Initial & Last Name & Degree
Kaid Darwiche
Facility Name
Thoraxklinik
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kreuter, PD
Phone
06221/396 0
Facility Name
University Hospital Tuebingen
City
Tuebingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juergen Hetzel, MD
Phone
0049-7071-2982714
Email
juergen.hetzel@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Michael Boeckeler, MD
Facility Name
Ospedale G.B. Morgagni
City
Forlì
ZIP/Postal Code
47100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Poletti, Prof.
Phone
0543 735452
Facility Name
Respiratory Department Hospital of Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfons Torrego
Phone
(+34) 93 556 59 72
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6LR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athol Wells
Phone
+44 (0)20 7352 8121

12. IPD Sharing Statement

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Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease

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