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OpenTrials
Completed

NCT Number: NCT05311345

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

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.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pneumothorax

    Time frame: 2 weeks

    Pneumothorax, hemorrhage, acute exacerbation and death

  2. Hemorrhage

    Time frame: 3 days

    Hemorrhage during the procedure

  3. Acute exacerbation

    Time frame: 100 days

    Acute exacerbation after the procedure

  4. Mortality

    Time frame: 100 days

    Mortality after the procedure

Secondary outcomes

  1. Diagnostic yield

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Apr 5, 2022
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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