Diagnosis, Lung Cancer, Lung Neoplasms
Conditions
Keywords
Cone-beam CT, Robotic assisted Bronchoscopy, Cios Spin, Ion endoluminal System, Advanced Bronchoscopy
Brief summary
This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 2 study arms (2x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.
Detailed description
This randomized-controlled-trial, classified as Category A under Art 6 ClinO-MD, investigates the potential benefits of integrating cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) into clinical practice for diagnosing pulmonary lesions. The study aims to enhance biopsy accuracy and safety by utilizing 3-dimensional reconstructions and increased flexibility of the bronchoscope tip. It targets two main clinical scenarios: peripheral lung lesions (PPLs) and other lung diseases requiring tissue biopsies. The hypothesis is that CBCT and RAB will significantly improve diagnostic yield compared to traditional 2D fluoroscopy techniques and endobronchial ultrasound. The trial will involve 300 participants in the overall observational study, with a nested randomized controlled trial (RCT) for specific lesion types, targeting 2x46 lesions for 2 study arms i) usual care, ii) CBCT and RAB . Primary endpoints include procedure time for the overall trial and diagnostic yield (ATS 2024 criteria) for the nested RCTs, analyzed via Pearson's Chi-squared test and multivariable logistic regression. Inclusion criteria encompass patients aged 18 or older, scheduled for bronchoscopy, with necessary pre-interventional exams and informed consent. Exclusion criteria include inability to tolerate the procedure, pregnancy, previous trial randomization, and specific lung conditions. The study's recruitment phase spans 24 months, with a 12-month follow-up, running from July 2024 to July 2027.
Interventions
DIAGNOSTIC_TESTRobotic Assisted Bronchoscopy
Cone-beam computed tomography (CBCT) technology and robotic-assisted bronchoscopy (RAB) present promising methods to enhance biopsy accuracy and procedural safety through 3-dimensional reconstructions and increased bronchoscope tip flexibility. Additionally, the transfer of navigational data between CBCT and RAB may further improve diagnostic yield. Given their distinct approaches to enhancing diagnostic outcomes, two separate study arms are warranted for CBCT and RAB.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged \>18 years * Scheduled for bronchoscopy in order to obtain at least 1 specimen(s) of the lung via transbronchial biopsy * Necessary periinterventional laboratory examinations and other examinations needed for the bronchoscopy * Informed consent
Exclusion criteria
* Not able to tolerate procedure (bronchoscopy or apnea for CBCT) * Previous randomization to an arm of the present trial * Endobronchial lesion causing lobar atelectasis * Inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders, or severe neurosis) * Pregnant or lactating women For nested RCTs (Trial A + B): * A: At least 1 peripheral lung lesion suspicious for lung cancer, beyond the visual range of the bronchoscope, rounded or irregular opacity, may be well or poorly defined, measuring ≤3 cm in diameter of the short axis (in CT scan) * B:At least 1 peripheral target lung lesion of any kind beyond the visual range of the bronchoscope (measuring \>3 cm in diameter of the short axis and/or with an interstitial pattern)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield | Including a 12-month follow-up (clinical data) | ATS 2024 consensus criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation exposure | During Intervention | Dose area product |
| Safety profile | During Intervention | Rates of complications (bleeding, pneumothorax, pneumonia) |
| Diagnostic accuracy for milignancy | Including a 12-month follow-up (clinical data) | True positives + true negatives / true positives + true negatives + false positives + false negatives |
| Quality of biopsies | During Intervention | Number of malignant cells, suitability rates for further molecular pathological testing |
| Navigation success | During Intervention | Anatomical confirmation of the position of the catheter in front or within the lesion as confirmed by r-EBUS or CBCT \[not fluoroscopy\] |
Countries
Switzerland
Contacts
STUDY_DIRECTORThomas Gaisl, MD MPH PhD
University of Zurich
Outcome results
None listed