NCT05722340

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
PROCEDURE	Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy	An epidural anaesthesia associated with mild sedation requiring no ventilation is used.
PROCEDURE	Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy	Uses a traditional deep anaesthesia and one-lung ventilation

Timeline

• Start date: 2023-05-24
• Primary completion: 2026-11-24
• Completion: 2026-11-24
• First posted: 2023-02-10
• Last updated: 2026-04-02

Locations

1 site across 1 country: France