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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The level of diagnostic confidence based on centralized histology only
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NIVATS
Lung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS).
干预措施: Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy (Procedure)
IGAVATS
Lung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS).
干预措施: Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy (Procedure)
结局指标
主要结局
The level of diagnostic confidence based on centralized histology only
时间窗: 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.
次要结局
- Classification according to ATS/ERS at MDA-2(Day 7 to day 28)
- Inter-histologist concordance for ATS/ERS categories(Day 1 to 15)
- Post-RR time (hours)(Day 1 to 15)
- First drink time (minutes)(Day 0)
- Forced vital capacity (% theoretical value)(12 months)
- 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)
- Volume (cc) of biopsy specimens(Day 1 to 15)
- Preparation time (minutes)(Day 0)
- Post-operative fasting time (hours)(Day 0)
- Length of initial hospitalization stay (hours)(Expected maximum of 15 days)
- Forced vital capacity (litres)(12 months)
- Presence / absence of complications(12 months)
- The level of diagnostic confidence based on routine histology only(Day 1 to day 15)
- The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2(Day 7 to day 28)
- Longest length (mm) of biopsy specimens(Day 1 to 15)
- Weight (g) of biopsy specimens(Day 1 to 15)
- Visual analogue scale score for post-operative pain(Day 1, morning after surgery)
- Time to dischargeability(Days 1 to 15)
- Recovery room (RR) time (minutes)(Day 0)
- Patient satisfaction (satisfied vs unsatisfied)(Hospital discharge (expected maximum of 15 days))
- Cumulative days of exacerbation(12 months)
- Days alive, not exacerbating and not in hospital(12 months)
- Classification according to ATS/ERS at MDA-1(Day -28 to day -3)
- Numerical scale for biopsy quality(Day 1 to 15)
- OR time (minutes)(Day 0)
- Time with chest tube in place (hours)(Day 0)
- Cumulative days of hospitalization(12 months)
- Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score(12 months)
- Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score(12 months)
- Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score(12 months)
- Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score(12 months)
- Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score(12 months)