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Cryo- vs Surgical Lung biopsy for diagnosing interstitial lung disease: a randomized controlled trial

Cryo- vs Surgical Lung biopsy for diagnosing interstitial lung disease: a randomized controlled trial - The COLD study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48733
Enrollment
66
Registered
2019-01-31
Start date
2019-04-08
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse parenchymal lung diseases interstitial lung disease

Interventions

Randomization between transbronchial cryobiopsy (followed by surgical biopsy in case of inconclusive results) versus immediate surgical biopsy.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: interstitial lung disease based on HR-CT scan and a ILD-multidisciplinary discussion panel decides there is a need for lungbiopsy.

Exclusion criteria

Exclusion criteria: Inability and willingness to provide informed consent, Inability to comply with study protocol, Use of carbasalate calcium, clopidogrel, or other new anti-platelet therapy that cannot be stopped temporarily, Thrombocytopenia 50 mmHg), Diffusing capacity 35 * Hypoxemia, PaO2

Design outcomes

Primary

MeasureTime frame
(prolonged) need for chest tube drainage

Secondary

MeasureTime frame
complications, comprehensive complication index, in hospital stay, days with chest tube, pain and pain medication use, health related quality of life, diagnostic yield and diagnostic confidence per diagnostic strategy and procedure, patient preference and health care costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)