Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging (RELIANT 2)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Peripheral Pulmonary Lesion; Lung Nodule, Solitary

Treatments: Device: Robotic assisted bronchoscopy (RAB); Device: Electromagnetic navigation bronchoscopy (ENB)

Study type: Interventional

Funder types: Other

Identifiers

NCT06654271

241103

Details and patient eligibility

About

RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.

Full description

Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. There are several technologies currently available to biopsy these lesions, including electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB). The latter is used clinically with either conventional fluoroscopy or with cone beam computed tomography (CBCT) guidance, which provides real time 3-dimensional images during the procedure. Recently, CBCT has been integrated with RAB, which allows for automatic update of the lesion location. This update is believed to increase the diagnostic yield of the procedure. Given this new upgrade, we designed this pragmatic, randomized controlled study to test the hypothesis that the diagnostic yield of RAB with integrated CBCT is superior to ENB with integrated digital tomosynthesis in patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Patients undergoing advanced diagnostic bronchoscopy to biopsy a lung lesion will be assigned to either the RAB or ENB based on cluster randomization. Randomization will be revealed each morning before procedures are started. Any advanced diagnostic bronchoscopy scheduled on that day will be performed with the device (RAB or ENB) allocated to that room on that day. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age at time of bronchoscopy
• Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion

Exclusion criteria

• Patient declines to participate
• Patients enrolled in another trial which requires the use of one specific navigational platform

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 2 patient groups

Robotic assisted bronchoscopy (RAB)

Active Comparator group

Description:

Robotic assisted bronchoscopy with integrated cone beam computed tomography

Treatment:

Device: Robotic assisted bronchoscopy (RAB)

Electromagnetic navigation bronchoscopy (ENB)

Active Comparator group

Description:

Electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis

Treatment:

Device: Electromagnetic navigation bronchoscopy (ENB)