Skip to main content
OpenTrials
Completed

NCT Number: NCT05722340

NIVATS Versus IGAVATS: a 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve

Montpellier, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy

Procedure

An epidural anaesthesia associated with mild sedation requiring no ventilation is used.

Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy

Procedure

Uses a traditional deep anaesthesia and one-lung ventilation

Primary outcomes

  1. The level of diagnostic confidence based on centralized histology only

    Time frame: 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 outcomes

  1. The level of diagnostic confidence based on routine histology only

    Time frame: 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.

  2. The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2

    Time frame: 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.

  3. Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2

    Time frame: 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.

  4. Classification according to ATS/ERS at MDA-1

    Time frame: Day -28 to day -3

    Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable

  5. Classification according to ATS/ERS at MDA-2

    Time frame: Day 7 to day 28

    Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable

  6. Inter-histologist concordance for ATS/ERS categories

    Time frame: Day 1 to 15

    Inter-histologist concordance for ATS/ERS categories

  7. Longest length (mm) of biopsy specimens

    Time frame: Day 1 to 15

    Longest length (mm) of biopsy specimens

  8. Volume (cc) of biopsy specimens

    Time frame: Day 1 to 15

    Volume (cc) of biopsy specimens

  9. Weight (g) of biopsy specimens

    Time frame: Day 1 to 15

    Weight (g) of biopsy specimens

  10. Numerical scale for biopsy quality

    Time frame: Day 1 to 15

    The histologist ranks biopsy quality from worst imaginable (0) to excellent (10).

  11. Preparation time (minutes)

    Time frame: Day 0

    Minutes lapsed between entering the surgical ward and entering the operating room (OR)

  12. OR time (minutes)

    Time frame: Day 0

    Minutes lapsed between entering and exiting the OR

  13. Recovery room (RR) time (minutes)

    Time frame: Day 0

    Minutes lapsed between exiting the OR and exiting the surgical ward.

  14. Post-RR time (hours)

    Time frame: Day 1 to 15

    Hours lapsed between exit from surgical ward, and discharge from hospital

  15. First drink time (minutes)

    Time frame: Day 0

    Minutes lapsed between application of last bandage on surgical wounds to first drink

  16. Post-operative fasting time (hours)

    Time frame: Day 0

    Hours lapsed between application of last bandage on surgical wounds to first meal

  17. Time with chest tube in place (hours)

    Time frame: Day 0

    Hours lapsed between application of last bandage on surgical wounds to removal of chest tube

  18. Visual analogue scale score for post-operative pain

    Time frame: 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.

  19. Patient satisfaction (satisfied vs unsatisfied)

    Time frame: Hospital discharge (expected maximum of 15 days)

    The patient will be asked to evaluate his/her satisfaction (satisfied vs unsatisfied)

  20. Time to dischargeability

    Time frame: 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.

  21. Length of initial hospitalization stay (hours)

    Time frame: Expected maximum of 15 days

    Length of initial hospitalization stay (hours)

  22. Cumulative days of hospitalization

    Time frame: 12 months

    Cumulative days of hospitalization

  23. Cumulative days of exacerbation

    Time frame: 12 months

    Cumulative days of exacerbation

  24. Days alive, not exacerbating and not in hospital

    Time frame: 12 months

    Days alive, not exacerbating and not in hospital

  25. Forced vital capacity (litres)

    Time frame: Day -28 to Day -1

    Forced vital capacity (litres)

  26. Forced vital capacity (litres)

    Time frame: 12 months

    Forced vital capacity (litres)

  27. Forced vital capacity (% theoretical value)

    Time frame: Day -28 to Day -1

    Forced vital capacity (% theoretical value)

  28. Forced vital capacity (% theoretical value)

    Time frame: 12 months

    Forced vital capacity (% theoretical value)

  29. Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score

    Time frame: Day -28 to Day -1

    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.

  30. Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score

    Time frame: 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.

  31. Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score

    Time frame: Day -28 to Day -1

    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.

  32. Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score

    Time frame: 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.

  33. Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score

    Time frame: Day -28 to Day -1

    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.

  34. Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score

    Time frame: 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.

  35. Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score

    Time frame: Day -28 to Day -1

    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.

  36. Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score

    Time frame: 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.

  37. Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score

    Time frame: Day -28 to Day -1

    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.

  38. Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score

    Time frame: 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.

  39. Presence / absence of complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie)

Registry information

Official study 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

Acronym: NIVATS-2

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.