NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases

Lung Diseases, Interstitial Clinical Trial

— NIVATS-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722340
• Other study ID #: RECHMPL 22_0042
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: November 24, 2025

Study information

• Verified date: June 2023
• Source: University Hospital, Montpellier
• Contact: Timothée JOUITTEAU, Doctor
• Phone: 003467335958
• Email: t-jouitteau[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 24, 2025
• Est. primary completion date: November 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial

Intervention

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

Locations

Country	Name	City	State
France	Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 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.	Day 1 to day 15
Secondary	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.	Day 1 to day 15
Secondary	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.	Day 7 to day 28
Secondary	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.	Day 7 to day 28
Secondary	Classification according to ATS/ERS at MDA-1	Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable	Day -28 to day -3
Secondary	Classification according to ATS/ERS at MDA-2	Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable	Day 7 to day 28
Secondary	Inter-histologist concordance for ATS/ERS categories	Inter-histologist concordance for ATS/ERS categories	Day 1 to 15
Secondary	Longest length (mm) of biopsy specimens	Longest length (mm) of biopsy specimens	Day 1 to 15
Secondary	Volume (cc) of biopsy specimens	Volume (cc) of biopsy specimens	Day 1 to 15
Secondary	Weight (g) of biopsy specimens	Weight (g) of biopsy specimens	Day 1 to 15
Secondary	Numerical scale for biopsy quality	The histologist ranks biopsy quality from worst imaginable (0) to excellent (10).	Day 1 to 15
Secondary	Preparation time (minutes)	Minutes lapsed between entering the surgical ward and entering the operating room (OR)	Day 0
Secondary	OR time (minutes)	Minutes lapsed between entering and exiting the OR	Day 0
Secondary	Recovery room (RR) time (minutes)	Minutes lapsed between exiting the OR and exiting the surgical ward.	Day 0
Secondary	Post-RR time (hours)	Hours lapsed between exit from surgical ward, and discharge from hospital	Day 1 to 15
Secondary	First drink time (minutes)	Minutes lapsed between application of last bandage on surgical wounds to first drink	Day 0
Secondary	Post-operative fasting time (hours)	Hours lapsed between application of last bandage on surgical wounds to first meal	Day 0
Secondary	Time with chest tube in place (hours)	Hours lapsed between application of last bandage on surgical wounds to removal of chest tube	Day 0
Secondary	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.	Day 1, morning after surgery
Secondary	Patient satisfaction (satisfied vs unsatisfied)	The patient will be asked to evaluate his/her satisfaction (satisfied vs unsatisfied)	Hospital discharge (expected maximum of 15 days)
Secondary	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.	Days 1 to 15
Secondary	Length of initial hospitalization stay (hours)	Length of initial hospitalization stay (hours)	Expected maximum of 15 days
Secondary	Cumulative days of hospitalization	Cumulative days of hospitalization	12 months
Secondary	Cumulative days of exacerbation	Cumulative days of exacerbation	12 months
Secondary	Days alive, not exacerbating and not in hospital	Days alive, not exacerbating and not in hospital	12 months
Secondary	Forced vital capacity (litres)	Forced vital capacity (litres)	Day -28 to Day -1
Secondary	Forced vital capacity (litres)	Forced vital capacity (litres)	12 months
Secondary	Forced vital capacity (% theoretical value)	Forced vital capacity (% theoretical value)	Day -28 to Day -1
Secondary	Forced vital capacity (% theoretical value)	Forced vital capacity (% theoretical value)	12 months
Secondary	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.	Day -28 to Day -1
Secondary	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.	12 months
Secondary	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.	Day -28 to Day -1
Secondary	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.	12 months
Secondary	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.	Day -28 to Day -1
Secondary	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.	12 months
Secondary	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.	Day -28 to Day -1
Secondary	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.	12 months
Secondary	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.	Day -28 to Day -1
Secondary	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.	12 months
Secondary	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.	12 months