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ID
Source
Brief title
Health condition
Interstitial lung disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Need for (prolonged) chest tube drainage
Secondary outcome
Complications, comprehensive complication index, length of hospital stay, days with chest tube, pain, quality of life, diagnostic yield, patient preference and health care costs.
Background summary
1) RCT to compare patient- and healthcare burden of bronchoscopic cryobiopsy (followed by surgical lung biopsy in case of non-diagnostic results) versus immediate surgical biopsy in patients with an interstitial lung disease.
(performed in a population of patients fit to undergo surgical lung biopsy, n=46)
2) Observational cohort of bronchoscopic cryobiopsy in ILD
(performed in a population of patients not fit for surgical lung biopsy, n=20)
Study objective
A diagnostic strategy starting with bronchoscopic cryobiopsy is associated with a reduced need for chest tube drainage in comparison to a diagnostic strategy with immediate surgical lung biopsy, and is therefore associated with a lower patient- and healthcare burden, while remaining a similar high diagnostic yield.
Study design
3 months follow up
Intervention
Step up diagnostic strategy starting with cryobiopsy (only followed by surgical biopsy in the case of non-diagnostic cryobiopsy) vs standard (immediate surgical biopsy)
Marianne van de Pol
+31 (0)20 566 1285
m.a.vandepol@amc.nl
Marianne van de Pol
+31 (0)20 566 1285
m.a.vandepol@amc.nl
Inclusion criteria
Adults with an interstitial lung disease and an indication for lung tissue sampling
Exclusion criteria
Use of clopidogrel, or other new anti-platelet therapy, or anticoagulant drugs that cannot be stopped temporarily, thrombocytopenia (< 70 x10^9/L), History of pulmonary hypertension (systolic pulmonary artery pressure > 50 mmHg), Diffusing capacity < 30%, Forced vital capacity <50%, Forced expiratory volume in the first second (FEV1) <0,8L or <50% of predicted value, Body mass index > 35, Pregnancy
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7634 |
| Other | METC Amsterdam UMC : METC2018_224 |