Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy

N/AActive Not RecruitingNCT06489678

University of Zurich300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Lung Neoplasms Diagnosis Lung Cancer

Interventions

Robotic Assisted BronchoscopyDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Diagnostic Yield

ATS 2024 consensus criteria

Time frame: Including a 12-month follow-up (clinical data)

Secondary Outcomes

Radiation exposure

Dose area product

Time frame: During Intervention

Safety profile

Rates of complications (bleeding, pneumothorax, pneumonia)

Time frame: During Intervention

Diagnostic accuracy for milignancy

True positives + true negatives / true positives + true negatives + false positives + false negatives

Time frame: Including a 12-month follow-up (clinical data)

Quality of biopsies

Number of malignant cells, suitability rates for further molecular pathological testing

Time frame: During Intervention

Navigation success

Anatomical confirmation of the position of the catheter in front or within the lesion as confirmed by r-EBUS or CBCT \[not fluoroscopy\]

Time frame: During Intervention

Data from ClinicalTrials.gov

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