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

University Hospital Tuebingen100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Interstitial Lung Disease

Interventions

Lung biopsyPROCEDURE

transbronchial lung biopsy. First kryobiopsy, second open biopsy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

Ruhrlandklinik

Essen, Germany

RECRUITING

Thoraxklinik

Heidelberg, Germany

RECRUITING

University Hospital Tuebingen

Tübingen, Germany

Outcomes

Primary Outcomes

Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy

Time frame: two weeks

Secondary Outcomes

numer of bleeding events

Time frame: 1 day

Rate of pneumothoraxes

Time frame: 1 day

numer of exacerbations after biopsy

Time frame: 6 weeks

Contribution of BAL and cryobiopsy to diagnosis

Time frame: 2 weeks

Size of specimen

Time frame: 2 weeks

Quality of specimen

Time frame: 2 weeks

Distribution of histological changes in the specimen

Time frame: 2 weeks

Influence of the size of the cryoprobe in the primary endpoint

Time frame: 2 weeks

Comparative group (out of trial) - who are referred for VATS directly ['positive control group']

Time frame: 6 weeks

Rate of exacerbations after cryobiopsy and after surgical biopsy

Time frame: 6 weeks

Data from ClinicalTrials.gov

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