Comparing two techniques for lung biopsy in patients with undetermined interstitial lung disease
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
This study is testing two different lung biopsy methods to see which one gives better results and experiences for patients with unclear interstitial lung disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05722340 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two groups of patients undergoing lung biopsy for undetermined interstitial lung disease (ILD) using different surgical techniques. One group will receive a non-intubated video-assisted thoracic surgery (NIVATS) approach, while the other will undergo intubated general anaesthesia video-assisted thoracic surgery (IGAVATS). The primary focus is on assessing diagnostic confidence as determined by histologists, along with secondary evaluations of biopsy quality, surgical performance, patient outcomes, and quality of life. The study will help determine which technique provides better diagnostic results and patient experiences.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have suspected interstitial lung disease and require a surgical lung biopsy for diagnosis.
Not a fit: Patients with contraindications for surgery, severe comorbidities, or those unable to comply with trial procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy and safety of lung biopsies for patients with undetermined interstitial lung disease.
How similar studies have performed: While this approach is innovative, similar studies have shown varying success in improving biopsy techniques and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montpellier
- Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Timothée JOUITTEAU, Doctor
- Email: t-jouitteau@chu-montpellier.fr
- Phone: 003467335958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.