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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02563730

Collaborator

(none)

100

Enrollment

Locations

Arm

16.7

Patients Per Site

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease	Procedure: Lung biopsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lung biopsy assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS	Procedure: Lung biopsy transbronchial lung biopsy. First kryobiopsy, second open biopsy

Arm

Intervention/Treatment

Experimental: Lung biopsy

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

Procedure: Lung biopsy

transbronchial lung biopsy. First kryobiopsy, second open biopsy

Outcome Measures

Primary Outcome Measures

Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy [two weeks]

Secondary Outcome Measures

numer of bleeding events [1 day]
Rate of pneumothoraxes [1 day]
numer of exacerbations after biopsy [6 weeks]
Contribution of BAL and cryobiopsy to diagnosis [2 weeks]
Size of specimen [2 weeks]
Quality of specimen [2 weeks]
Distribution of histological changes in the specimen [2 weeks]
Influence of the size of the cryoprobe in the primary endpoint [2 weeks]
Comparative group (out of trial) - who are referred for VATS directly ['positive control group'] [6 weeks]
Rate of exacerbations after cryobiopsy and after surgical biopsy [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ruhrlandklinik	Essen	Germany	45239
2	Thoraxklinik	Heidelberg	Germany	69126
3	University Hospital Tuebingen	Tuebingen	Germany
4	Ospedale G.B. Morgagni	Forlì	Italy	47100
5	Respiratory Department Hospital of Santa Creu i Sant Pau	Barcelona	Spain	08025
6	Royal Brompton Hospital	London	United Kingdom	SW3 6LR