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

Not Applicable

• Conditions: Interstitial Lung Disease
• Interventions: Procedure: Lung biopsy

• Registration Number: NCT02563730
• Lead Sponsor: University Hospital Tuebingen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-05-02
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy	two weeks

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Ruhrlandklinik; 🇩🇪 Essen, Germany

Thoraxklinik; 🇩🇪 Heidelberg, Germany

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany

Ospedale G.B. Morgagni; 🇮🇹 Forlì, Italy

Respiratory Department Hospital of Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Royal Brompton Hospital; 🇬🇧 London, United Kingdom