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

NCT ID: NCT02563730

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Interstitial Lung Disease

Keywords

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Cryobiopsy lung biopsy interstitial lung disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lung biopsy

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

Group Type EXPERIMENTAL

Lung biopsy

Intervention Type PROCEDURE

transbronchial lung biopsy. First kryobiopsy, second open biopsy

Interventions

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Lung biopsy

transbronchial lung biopsy. First kryobiopsy, second open biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Boeckeler, Michael

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruhrlandklinik

Essen, , Germany

Site Status RECRUITING

Thoraxklinik

Heidelberg, , Germany

Site Status RECRUITING

University Hospital Tuebingen

Tübingen, , Germany

Site Status RECRUITING

Ospedale G.B. Morgagni

Forlì, , Italy

Site Status RECRUITING

Respiratory Department Hospital of Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Royal Brompton Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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Germany Italy Spain United Kingdom

Facility Contacts

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Ulrich Costabel

Role: primary

Kaid Darwiche

Role: backup

Michael Kreuter, PD

Role: primary

Juergen Hetzel, MD

Role: primary

Poletti, Prof.

Role: primary

Alfons Torrego

Role: primary

Athol Wells

Role: primary

Other Identifiers

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CRYO-VATS

Identifier Type: -

Identifier Source: org_study_id