Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy (NCT06489678) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy
Switzerland300 participantsStarted 2024-06-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Diagnostic Yield
Timeframe: Including a 12-month follow-up (clinical data)