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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
Montpellier, France
Start Date
May 24, 2023
Primary Completion Date
November 24, 2026
Completion Date
November 24, 2026
Last Updated
November 25, 2024
24
ESTIMATED participants
Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy
PROCEDURE
Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy
PROCEDURE
Lead Sponsor
University Hospital, Montpellier
Collaborators
NCT04707781
NCT06122233
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04325217