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

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02563730
• Other study ID #: CRYO-VATS
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2015
• Last updated: October 25, 2016
• Start date: November 2014

Study information

• Verified date: October 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• Lung biopsy
transbronchial lung biopsy. First kryobiopsy, second open biopsy

Locations

Country	Name	City	State
Germany	Ruhrlandklinik	Essen
Germany	Thoraxklinik	Heidelberg
Germany	University Hospital Tuebingen	Tuebingen
Italy	Ospedale G.B. Morgagni	Forlì
Spain	Respiratory Department Hospital of Santa Creu i Sant Pau	Barcelona
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Countries where clinical trial is conducted

Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy		two weeks	No
Secondary	numer of bleeding events		1 day	Yes
Secondary	Rate of pneumothoraxes		1 day	Yes
Secondary	numer of exacerbations after biopsy		6 weeks	Yes
Secondary	Contribution of BAL and cryobiopsy to diagnosis		2 weeks	No
Secondary	Size of specimen		2 weeks	No
Secondary	Quality of specimen		2 weeks	No
Secondary	Distribution of histological changes in the specimen		2 weeks	No
Secondary	Influence of the size of the cryoprobe in the primary endpoint		2 weeks	No
Secondary	Comparative group (out of trial) - who are referred for VATS directly ['positive control group']		6 weeks	No
Secondary	Rate of exacerbations after cryobiopsy and after surgical biopsy		6 weeks	Yes