Clinical trial NCT05722340: NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases, Interstitial
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie)
First posted: 2023-02-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this prospective, parallel group, randomized (1:1), controlled, pilot trial, screening will take place during routine multidisciplinary assessment (MDA) meetings. The study is then presented to eligible patients during their next pre-surgical visits; if the patients are interested in participating, informed consent procedures are completed (again during routine visits) and the patients are randomized to two arms. In the experimental arm, patients will undergo NIVATS for lung biopsy, and in the standard arm, patients will undergo traditional IGAVATS for lung biopsy. Histology is then performed as usual, before entering a centralized pathway for a second analysis by an expert external to the study, and a second routine MDA convened (both blinded to study arms). Patients are followed-up for 12 months.
Primary purpose: DIAGNOSTIC

Brief 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.

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

Primary outcomes:
measure: The level of diagnostic confidence based on centralized histology only
timeFrame: Day 1 to day 15
Secondary outcomes:
measure: The level of diagnostic confidence based on routine histology only
timeFrame: Day 1 to day 15
measure: The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2
timeFrame: Day 7 to day 28
measure: Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2
timeFrame: Day 7 to day 28
measure: Classification according to ATS/ERS at MDA-1
timeFrame: Day -28 to day -3
measure: Classification according to ATS/ERS at MDA-2
timeFrame: Day 7 to day 28
measure: Inter-histologist concordance for ATS/ERS categories
timeFrame: Day 1 to 15
measure: Longest length (mm) of biopsy specimens
timeFrame: Day 1 to 15
measure: Volume (cc) of biopsy specimens
timeFrame: Day 1 to 15
measure: Weight (g) of biopsy specimens
timeFrame: Day 1 to 15
measure: Numerical scale for biopsy quality
timeFrame: Day 1 to 15
measure: Preparation time (minutes)
timeFrame: Day 0
measure: OR time (minutes)
timeFrame: Day 0
measure: Recovery room (RR) time (minutes)
timeFrame: Day 0
measure: Post-RR time (hours)
timeFrame: Day 1 to 15
measure: First drink time (minutes)
timeFrame: Day 0
measure: Post-operative fasting time (hours)
timeFrame: Day 0
measure: Time with chest tube in place (hours)
timeFrame: Day 0
measure: Visual analogue scale score for post-operative pain
timeFrame: Day 1, morning after surgery
measure: Patient satisfaction (satisfied vs unsatisfied)
timeFrame: Hospital discharge (expected maximum of 15 days)
measure: Time to dischargeability
timeFrame: Days 1 to 15
measure: Length of initial hospitalization stay (hours)
timeFrame: Expected maximum of 15 days
measure: Cumulative days of hospitalization
timeFrame: 12 months
measure: Cumulative days of exacerbation
timeFrame: 12 months
measure: Days alive, not exacerbating and not in hospital
timeFrame: 12 months
measure: Forced vital capacity (litres)
timeFrame: Day -28 to Day -1
measure: Forced vital capacity (litres)
timeFrame: 12 months
measure: Forced vital capacity (% theoretical value)
timeFrame: Day -28 to Day -1
measure: Forced vital capacity (% theoretical value)
timeFrame: 12 months
measure: Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
timeFrame: Day -28 to Day -1
measure: Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
timeFrame: 12 months
measure: Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
timeFrame: Day -28 to Day -1
measure: Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
timeFrame: 12 months
measure: Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
timeFrame: Day -28 to Day -1
measure: Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
timeFrame: 12 months
measure: Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
timeFrame: Day -28 to Day -1
measure: Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
timeFrame: 12 months
measure: Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
timeFrame: Day -28 to Day -1
measure: Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
timeFrame: 12 months
measure: Presence / absence of complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
Study officials:
References: