The main objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease (ILD) in terms of diagnostic confidence as determined by histologists.
Patient with purported interstitial lung disease
Patient requiring a surgical lung biopsy to reinforce diagnosis according to current recommendations and validated by a multidisciplinary assessment
Minimum age: 18 years
Contra-indication for surgery
Uncontrolled oesophageal gastric reflux despite optimal treatment
Thoracic deformation (For example, pectus excavatum/carinatum or major scoliosis)
Risk of pleural adhesion (For example, patient who has already undergone thoracic surgery)
Parallel
Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy
Procedure/SurgeryAn epidural anaesthesia associated with mild sedation requiring no ventilation is used.
Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy
Procedure/SurgeryUses a traditional deep anaesthesia and one-lung ventilation
The level of diagnostic confidence based on centralized histology only
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores \<1 corresponding to "alternate diagnosis", scores \>=1 and \<4 corresponding to "indeterminate", scores \>=4 and \<7 corresponding to "probable", and scores \>=7 corresponding to "highly probable" categories.
The level of diagnostic confidence based on routine histology only
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores \<1 corresponding to "alternate diagnosis", scores \>=1 and \<4 corresponding to "indeterminate", scores \>=4 and \<7 corresponding to "probable", and scores \>=7 corresponding to "highly probable" categories.
The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores \<1 corresponding to "alternate diagnosis", scores \>=1 and \<4 corresponding to "indeterminate", scores \>=4 and \<7 corresponding to "probable", and scores \>=7 corresponding to "highly probable" categories.
Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores \<1 corresponding to "alternate diagnosis", scores \>=1 and \<4 corresponding to "indeterminate", scores \>=4 and \<7 corresponding to "probable", and scores \>=7 corresponding to "highly probable" categories.
Classification according to ATS/ERS at MDA-1
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
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University Hospital, Montpellier
Lead sponsor
Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie)
Collaborator
