NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases (NIVATS-2)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Lung Diseases, Interstitial

Treatments: Procedure: Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy; Procedure: Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05722340

RECHMPL 22_0042

Details and patient eligibility

About

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.

Full description

The primary 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. The experimental arm will be operated under a neoteric non-intubated video assisted thoracic surgery (NIVATS) technique and the comparator arm under a usual intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) technique.

Secondarily, the two groups will also be compared in terms of: (i) further variables associated with histology, biopsy quality and size; (ii) surgical performance, (iii) patient trajectories and lung function; (iv) quality of life, and (v) harms.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

NIVATS

Experimental group

Description:

Lung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS).

Treatment:

Procedure: Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy

IGAVATS

Active Comparator group

Description:

Lung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS).

Treatment:

Procedure: Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy