Endoscopic Treatment

Official title

Endoscopic Treatment With 3D Customized Versus Standard Stent for Non-malignant Airway Stenoses: A Randomized Controlled Trial

Overview

The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.

Interventions

• Other Informed consent
  During the pre-inclusion/inclusion visit, the investigator informs the participant and answers all questions regarding the purpose, nature of the constraints, foreseeable risks and the expected benefits of the clinical investigation. The investigating physician then provides the participant with a copy of the information note and informed consent form. After this information session, the participant is granted a reflection period. If the participant agrees to participate
• Other Eligibility criteria check
  The investigator also specifies the participant's rights in the context of research and checks the eligibility criteria.
• Other Randomisation
  When an investigator wishes to perform the randomisation after checking the eligibility criteria and consent of the participant, he/she will connect to the dedicated Clinsight Website.
• Behavioral Dyspnea-12 questionnaire
  The DYSPNEA-12 questionnaire helps to understand how shortness of breath impacts a patient's life. This questionnaire contains 12 questions that assess the physical and emotional aspects of dyspnea in daily life by checking one of the following boxes: not at all, slightly, moderately, severely
• Behavioral VQ11 questionnaire
  The VQ11 questionnaire is a quality of life questionnaire. It contains 11 statements that express feelings about the consequences of a respiratory illness. For each statement, the patient must check the intensity that corresponds to their experience from among: not at all, a little, moderately, a lot, and extremely.
• Behavioral EQ-5D-5L questionnaire
  This questionnaire assesses the patient's mobility, autonomy, activities, pain, and anxiety using 5 items. For each item, the patient must select the situation that best describes them from among 5 options: no problem, mild problems, moderate problems, severe problems, or unable to function.
• Other Spirometry
  non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1)
• Radiation Chest CT scan
  High resolution chest CT scan without injection of contrast medium. The scanner required for the manufacture of the prosthesis must be a high-resolution CT scanner, the recommendations for which are specified in the order file for a 3D stent
• Procedure Commercially Stent Implantation
  During the commercially stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse.
• Procedure Experimental Stent Implantation
  During the experimental stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse.

Primary outcome measures

• Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s) [Time frame: 47 months]

Secondary outcome measures (9)

• Rate (percent) of all adverse events [Time frame: 15 months]
• Evolution in dyspnea [Time frame: 15 months]
• Evolution in dyspnea [Time frame: 15 months]
• Evolution of quality of life [Time frame: 15 months]
• Evolution of quality of life [Time frame: 15 months]
• Change in pulmonary function tests [Time frame: 15 months]
• Change in pulmonary function tests [Time frame: 15 months]
• Change in pulmonary function tests [Time frame: 15 months]
• Change in pulmonary function tests [Time frame: 15 months]

Eligibility criteria

Inclusion criteria

• Age >18 years,
• Central non-malignant symptomatic (dyspnea > grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma),
• To have access to a personal telephone for the teleconsultation scheduled in the protocol,
• Informed consent signed,
• Health insurance beneficiary.

Exclusion criteria

• Acute respiratory distress,
• Mechanical ventilation,
• Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation,
• Malignant stenosis,
• Pregnancy or breast-feeding,
• A situation in which emergency or semi-emergency intervention (less than 48 hours) may be anticipated (like an acute respiratory distress for example),
• Patient under legal protection, - Participation in another study with an exclusion period still in progress,
• Impossibility of giving the person informed information and of ensuring the subject's compliance due to impaired physical and/or psychological health.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 6 centers

• Hôpital Marie Lannelongue / Institut Gustave Roussy — Le Plessis-Robinson
• Institut Cœur Poumon - CHU Lille — Lille
• CHU Limoges — Limoges
• CHRU Strasbourg — Strasbourg
• Hôpital Foch — Suresnes
• Larrey Hospital — Toulouse

Identifiers

NCT: NCT07727824 · RC31/24/0324

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗