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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2026-11-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Diseases, Interstitial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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NIVATS

Lung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS).

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

IGAVATS

Lung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS).

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Uses a traditional deep anaesthesia and one-lung ventilation

Interventions

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

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

Intervention Type PROCEDURE

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

Uses a traditional deep anaesthesia and one-lung ventilation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No