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

University Hospital Tuebingen

Status: Unknown

Conditions: Interstitial Lung Disease

Treatments: Procedure: Lung biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02563730

CRYO-VATS

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Lung biopsy

Experimental group

Description:

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

Treatment:

Procedure: Lung biopsy