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

NCT05722340 | Recruiting

• 1 other identifier: RECHMPL 22_0042
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (39)

• 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

• 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

• Classification according to ATS/ERS at MDA-1

  Day -28 to day -3

• Classification according to ATS/ERS at MDA-2

  Day 7 to day 28

Study Arms (2)

NIVATS

EXPERIMENTAL

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

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

IGAVATS

ACTIVE COMPARATOR

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

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

Interventions

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

Uses a traditional deep anaesthesia and one-lung ventilation

IGAVATS

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

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

NIVATS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• Non-beneficiary of the French single-payer national medical insurance system
• Lack of signed informed consent

Sponsors & Collaborators

• Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie): collaborator
• University Hospital, Montpellier: lead

Study Sites (1)

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

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Timothée JOUITTEAU, Doctor

CONTACT

003467335958; t-jouitteau@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 10, 2023
• Study Start: May 24, 2023
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): November 24, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 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.
• Access Criteria: The conditions under which members of the public will be granted access to datasets are: * The data will be used/examined in a not-for-profit manner; * The data will not be used in an attempt to identify a participant or group of participants; * The user does not work for a private insurance company; * The data will not be used in support of any kind of private insurance policy or health penalties; * The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights; * The user will state why they wish to access the data. * If the data do not fulfil the requirements of the reference methodology (MR-00X) (ex: data about religion, etc.), the appropriate CNIL approval has to be obtained by the user. * If the data will be used outside the European Union, standard contractual clauses have to be signed between Montpellier University Hospital and the user before sharing data.

Locations

FR (1)