NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial, called NIVATS Versus IGAVATS, is looking at different methods to perform lung biopsies for patients with uncertain interstitial lung diseases (ILD). The goal is to see which method gives doctors more confidence in the results they get from the biopsy. This is important because a clear diagnosis can help in deciding the best treatment for patients.

To participate in this trial, you need to be at least 18 years old and have a diagnosis of ILD that requires a surgical lung biopsy. However, there are some reasons that might prevent someone from joining, such as certain health conditions or risks associated with surgery. If you do take part, you can expect to undergo the biopsy procedure and follow-up visits to monitor your health. This study is currently recruiting participants, and your involvement could help improve the understanding and treatment of interstitial lung diseases in the future.

Gender

ALL

Eligibility criteria

• 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
• Exclusion Criteria:
• • 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