NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
- Conditions
- Lung Diseases, Interstitial
- Interventions
- Procedure: Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsyProcedure: Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy
- Registration Number
- NCT05722340
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NIVATS Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy Lung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS). IGAVATS Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy Lung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS).
- Primary Outcome Measures
Name Time Method The level of diagnostic confidence based on centralized histology only Day 1 to day 15 The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores \<1 corresponding to "alternate diagnosis", scores \>=1 and \<4 corresponding to "indeterminate", scores \>=4 and \<7 corresponding to "probable", and scores \>=7 corresponding to "highly probable" categories.
- Secondary Outcome Measures
Name Time Method OR time (minutes) Day 0 Minutes lapsed between entering and exiting the OR
Classification according to ATS/ERS at MDA-2 Day 7 to day 28 Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Inter-histologist concordance for ATS/ERS categories Day 1 to 15 Inter-histologist concordance for ATS/ERS categories
Post-RR time (hours) Day 1 to 15 Hours lapsed between exit from surgical ward, and discharge from hospital
First drink time (minutes) Day 0 Minutes lapsed between application of last bandage on surgical wounds to first drink
Forced vital capacity (% theoretical value) 12 months Forced vital capacity (% theoretical value)
Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2 Day 7 to day 28 The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores \<1 corresponding to "alternate diagnosis", scores \>=1 and \<4 corresponding to "indeterminate", scores \>=4 and \<7 corresponding to "probable", and scores \>=7 corresponding to "highly probable" categories.
Volume (cc) of biopsy specimens Day 1 to 15 Volume (cc) of biopsy specimens
Preparation time (minutes) Day 0 Minutes lapsed between entering the surgical ward and entering the operating room (OR)
Post-operative fasting time (hours) Day 0 Hours lapsed between application of last bandage on surgical wounds to first meal
Length of initial hospitalization stay (hours) Expected maximum of 15 days Length of initial hospitalization stay (hours)
Forced vital capacity (litres) 12 months Forced vital capacity (litres)
Presence / absence of complications 12 months Complications will be listed and classified (Minor: (1) Any complication without need for pharmacologic treatment or other intervention; (2) Any complication that requires pharmacologic treatment or minor intervention only; Major: (3) Any complication that requires surgical, radiologic, endoscopic intervention, or multitherapy; (3a) Intervention does not require general anesthesia; (3b) Intervention requires general anesthesia; (4) Any complication requiring intensive care unit management and life support; (4a) Single organ dysfunction; (4b) Multiorgan dysfunction; (5) Any complication leading to the death of the patient.
The level of diagnostic confidence based on routine histology only Day 1 to day 15 The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores \<1 corresponding to "alternate diagnosis", scores \>=1 and \<4 corresponding to "indeterminate", scores \>=4 and \<7 corresponding to "probable", and scores \>=7 corresponding to "highly probable" categories.
The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2 Day 7 to day 28 The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores \<1 corresponding to "alternate diagnosis", scores \>=1 and \<4 corresponding to "indeterminate", scores \>=4 and \<7 corresponding to "probable", and scores \>=7 corresponding to "highly probable" categories.
Longest length (mm) of biopsy specimens Day 1 to 15 Longest length (mm) of biopsy specimens
Weight (g) of biopsy specimens Day 1 to 15 Weight (g) of biopsy specimens
Visual analogue scale score for post-operative pain Day 1, morning after surgery The patient will be asked to evaluate his/her level of post-operative pain using a numeric rating scale (0-10) the morning after surgery where 0 represents no pain, and 10 represents the worse possible pain.
Time to dischargeability Days 1 to 15 Dischargeability is defined as meeting the following criteria: (i) satisfactory pain control via oral analgesia; (ii) ability to mobilize and return to usual autonomy; (iii) absence of clinical, laboratory and radiological complications; (iv) stable respiratory state compatible pre-surgical state and home discharge; (v) vital signs are normal for the patient; (vi) chest tube removal \>12 hours.
Recovery room (RR) time (minutes) Day 0 Minutes lapsed between exiting the OR and exiting the surgical ward.
Patient satisfaction (satisfied vs unsatisfied) Hospital discharge (expected maximum of 15 days) The patient will be asked to evaluate his/her satisfaction (satisfied vs unsatisfied)
Cumulative days of exacerbation 12 months Cumulative days of exacerbation
Days alive, not exacerbating and not in hospital 12 months Days alive, not exacerbating and not in hospital
Classification according to ATS/ERS at MDA-1 Day -28 to day -3 Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Numerical scale for biopsy quality Day 1 to 15 The histologist ranks biopsy quality from worst imaginable (0) to excellent (10).
Time with chest tube in place (hours) Day 0 Hours lapsed between application of last bandage on surgical wounds to removal of chest tube
Cumulative days of hospitalization 12 months Cumulative days of hospitalization
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score 12 months In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score 12 months In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score 12 months In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score 12 months In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score 12 months In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Trial Locations
- Locations (1)
Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
🇫🇷Montpellier, France