Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIVATS | Experimental | Lung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS). |
|
| IGAVATS | Active Comparator | Lung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy | Procedure | An epidural anaesthesia associated with mild sedation requiring no ventilation is used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothée JOUITTEAU, Doctor | Contact | 003467335958 | t-jouitteau@chu-montpellier.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve | Recruiting | Montpellier | France |
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study.
Data will be made available to persons who address a reasonable request to the study director.
Individual participant data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.
The study protocol, participant Information materials, worksheet and data sharing plan will also be made available to the public.
Datasets that underlie the results reported in the article (text, tables, figures, and appendices) can be requested after the publication process has been completed.
The study protocol will be published in an open-access, peer-reviewed journal. Other key documents will be made available on the Open Science Framework as they are finalized.
The conditions under which members of the public will be granted access to datasets are:
Not provided
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.
Not provided
Not provided
To assure the blinding of non-surgical study staff (MDA participants, histologists, etc), allocation results in the electronic case report (eCRF) form are made available to designated surgical staff only. Patients, investigators / outcome assessors / care givers and study staff are blinded to allocation results in as much as possible.
Only designated surgical staff (identified prior to centre initiation and kept to a strict necessary minimum) not otherwise involved in outcome assessment or patient care have access to allocation results on the eCRF and are summoned to maintain secrecy.
Data analysts will not be involved in trial field logistics and will be blinded. During analyses, when group assignments are first required, they will only be revealed as "group A" or "group B". Only when analyses have been completed will the exact nature of groups be revealed.
| Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy | Procedure | Uses a traditional deep anaesthesia and one-lung ventilation |
|
| 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. | 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. | 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 | 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 | Day 7 to day 28 |
| Inter-histologist concordance for ATS/ERS categories | Inter-histologist concordance for ATS/ERS categories | Day 1 to 15 |
| Longest length (mm) of biopsy specimens | Longest length (mm) of biopsy specimens | Day 1 to 15 |
| Volume (cc) of biopsy specimens | Volume (cc) of biopsy specimens | Day 1 to 15 |
| Weight (g) of biopsy specimens | Weight (g) of biopsy specimens | Day 1 to 15 |
| Numerical scale for biopsy quality | The histologist ranks biopsy quality from worst imaginable (0) to excellent (10). | Day 1 to 15 |
| Preparation time (minutes) | Minutes lapsed between entering the surgical ward and entering the operating room (OR) | Day 0 |
| OR time (minutes) | Minutes lapsed between entering and exiting the OR | Day 0 |
| Recovery room (RR) time (minutes) | Minutes lapsed between exiting the OR and exiting the surgical ward. | Day 0 |
| Post-RR time (hours) | Hours lapsed between exit from surgical ward, and discharge from hospital | Day 1 to 15 |
| First drink time (minutes) | Minutes lapsed between application of last bandage on surgical wounds to first drink | Day 0 |
| Post-operative fasting time (hours) | Hours lapsed between application of last bandage on surgical wounds to first meal | Day 0 |
| Time with chest tube in place (hours) | Hours lapsed between application of last bandage on surgical wounds to removal of chest tube | 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. | Day 1, morning after surgery |
| 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) |
| 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 |
| Length of initial hospitalization stay (hours) | Length of initial hospitalization stay (hours) | Expected maximum of 15 days |
| Cumulative days of hospitalization | Cumulative days of hospitalization | 12 months |
| Cumulative days of exacerbation | Cumulative days of exacerbation | 12 months |
| Days alive, not exacerbating and not in hospital | Days alive, not exacerbating and not in hospital | 12 months |
| Forced vital capacity (litres) | Forced vital capacity (litres) | Day -28 to Day -1 |
| Forced vital capacity (litres) | Forced vital capacity (litres) | 12 months |
| Forced vital capacity (% theoretical value) | Forced vital capacity (% theoretical value) | Day -28 to Day -1 |
| Forced vital capacity (% theoretical value) | Forced vital capacity (% theoretical value) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 months |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided