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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
24
An epidural anaesthesia associated with mild sedation requiring no ventilation is used.
Uses a traditional deep anaesthesia and one-lung ventilation
Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
Montpellier, France
RECRUITINGThe level of diagnostic confidence based on centralized histology only
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.
Time frame: Day 1 to day 15
The level of diagnostic confidence based on routine histology only
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.
Time frame: Day 1 to day 15
The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2
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.
Time frame: Day 7 to day 28
Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 7 to day 28
Classification according to ATS/ERS at MDA-1
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Time frame: Day -28 to day -3
Classification according to ATS/ERS at MDA-2
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Time frame: Day 7 to day 28
Inter-histologist concordance for ATS/ERS categories
Inter-histologist concordance for ATS/ERS categories
Time frame: Day 1 to 15
Longest length (mm) of biopsy specimens
Longest length (mm) of biopsy specimens
Time frame: Day 1 to 15
Volume (cc) of biopsy specimens
Volume (cc) of biopsy specimens
Time frame: Day 1 to 15
Weight (g) of biopsy specimens
Weight (g) of biopsy specimens
Time frame: Day 1 to 15
Numerical scale for biopsy quality
The histologist ranks biopsy quality from worst imaginable (0) to excellent (10).
Time frame: Day 1 to 15
Preparation time (minutes)
Minutes lapsed between entering the surgical ward and entering the operating room (OR)
Time frame: Day 0
OR time (minutes)
Minutes lapsed between entering and exiting the OR
Time frame: Day 0
Recovery room (RR) time (minutes)
Minutes lapsed between exiting the OR and exiting the surgical ward.
Time frame: Day 0
Post-RR time (hours)
Hours lapsed between exit from surgical ward, and discharge from hospital
Time frame: Day 1 to 15
First drink time (minutes)
Minutes lapsed between application of last bandage on surgical wounds to first drink
Time frame: Day 0
Post-operative fasting time (hours)
Hours lapsed between application of last bandage on surgical wounds to first meal
Time frame: Day 0
Time with chest tube in place (hours)
Hours lapsed between application of last bandage on surgical wounds to removal of chest tube
Time frame: Day 0
Visual analogue scale score for post-operative pain
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 frame: Day 1, morning after surgery
Patient satisfaction (satisfied vs unsatisfied)
The patient will be asked to evaluate his/her satisfaction (satisfied vs unsatisfied)
Time frame: Hospital discharge (expected maximum of 15 days)
Time to dischargeability
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.
Time frame: Days 1 to 15
Length of initial hospitalization stay (hours)
Length of initial hospitalization stay (hours)
Time frame: Expected maximum of 15 days
Cumulative days of hospitalization
Cumulative days of hospitalization
Time frame: 12 months
Cumulative days of exacerbation
Cumulative days of exacerbation
Time frame: 12 months
Days alive, not exacerbating and not in hospital
Days alive, not exacerbating and not in hospital
Time frame: 12 months
Forced vital capacity (litres)
Forced vital capacity (litres)
Time frame: Day -28 to Day -1
Forced vital capacity (litres)
Forced vital capacity (litres)
Time frame: 12 months
Forced vital capacity (% theoretical value)
Forced vital capacity (% theoretical value)
Time frame: Day -28 to Day -1
Forced vital capacity (% theoretical value)
Forced vital capacity (% theoretical value)
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
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.
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
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.
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
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.
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
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.
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
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.
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
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.
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
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.
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
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.
Time frame: 12 months
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
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.
Time frame: Day -28 to Day -1
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
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.
Time frame: 12 months
Presence / absence of complications
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.
Time frame: 12 months