Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.

Completed

• Conditions: Interstitial Lung Disease

• Registration Number: NCT05311345
• Lead Sponsor: Aarhus University Hospital

Brief Summary

A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-06
• Primary Completion: 2019-09-10
• Study Completion: 2020-04-01
• Study First Submitted: 2020-04-17
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-27
• Last Update Submitted: 2022-03-27
• Study First Posted: 2022-04-05
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• >18years of age
• suspected of Interstitial lung Disease
• cryobiopsies performed.

Exclusion Criteria

• FVC below 50% of predicted
• DLCO below 35%
• Body Mass Index (BMI) above 35
• pulmonary hypertension with a tricuspidal gradient above 40 mmHg
• other cardiac or other comorbidities that would increase the risk of complications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemorrhage	3 days	Hemorrhage during the procedure
Mortality	100 days	Mortality after the procedure
Pneumothorax	2 weeks	Pneumothorax, hemorrhage, acute exacerbation and death
Acute exacerbation	100 days	Acute exacerbation after the procedure

Secondary Outcome Measures

Name	Time	Method
Diagnostic yield	1 month	Diagnostic yield is discussed at multidisciplinary team meetings i.e, adequate biopsies (\>50% alveolated biopsies), histologic pattern, kontribution to the diagnosis.