Informations générales (source: ClinicalTrials.gov)
Video-assisted Thoracic Surgery for Lung Biopsy Using Non-intubated (NIVATS) Versus Intubated General Anaesthesia (IGAVATS): a Randomized, Controlled, Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases (NIVATS-2)
Interventional
N/A
University Hospital, Montpellier (Voir sur ClinicalTrials)
mai 2023
novembre 2026
26 novembre 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve - Montpellier - France | Timothée JOUITTEAU, Doctor | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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)
- History of abnormal bleeding
- Predictable risk of difficult intubation
- Body mass index (BMI) > 30
- Severe cardiovascular comorbidity (For example, instable ischemic cardiomyopathy)
- Unable to comply with all trial procedures/visits (For example, language barriers,
upcoming move of household to another region, unwillingness to schedule the required
followup visits.)
- Protected populations according to the French Public Health Code Articles
L1121-5,6,8 (For example, pregnant, parturient or lactating women, prisoners, adults
under guardianship or otherwise unable to consent.)
- Potential interference from another study (The patient is participating in another
interventional study, or has done so in the past month, or is affected by an
exclusion period stipulated by a previous study.)
- Non-beneficiary of the French single-payer national medical insurance system
- Lack of signed informed consent