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…
ID
Bron
Verkorte titel
Aandoening
Interstitial lung disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Need for (prolonged) chest tube drainage
Achtergrond van het onderzoek
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)
Doel van het onderzoek
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.
Onderzoeksopzet
3 months follow up
Onderzoeksproduct en/of interventie
Step up diagnostic strategy starting with cryobiopsy (only followed by surgical biopsy in the case of non-diagnostic cryobiopsy) vs standard (immediate surgical biopsy)
Publiek
Marianne van de Pol
+31 (0)20 566 1285
m.a.vandepol@amc.nl
Wetenschappelijk
Marianne van de Pol
+31 (0)20 566 1285
m.a.vandepol@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adults with an interstitial lung disease and an indication for lung tissue sampling
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7634 |
| Ander register | METC Amsterdam UMC : METC2018_224 |