NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
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
University Hospital, Montpellier
24 participants
May 24, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria13
- 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
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Interventions
An epidural anaesthesia associated with mild sedation requiring no ventilation is used.
Uses a traditional deep anaesthesia and one-lung ventilation
Locations(1)
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NCT05722340