Lung Cancer (Diagnosis), Lung Nodule
Conditions
Keywords
Lung Biopsy, CT-Guided Percutaneous Biopsy, Robotic-Assisted Bronchoscopy, Shape-Sensing Robotic-Assisted Bronchoscopy (ssRAB), Transthoracic Needle Aspiration (TTNA), Bronchoscopy, Pulmonary Nodules
Brief summary
The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (≤2 cm): CT-guided percutaneous lung nodule biopsy and shape-sensing robotic-assisted bronchoscopy with cone-beam CT (ssRAB with CBCT).
Detailed description
CT-guided percutaneous biopsy and ssRAB with CBCT are two types of lung nodule biopsy procedures routinely used in clinical practice. The study is designed to evaluate the diagnostic efficacy and safety of ssRAB with CBCT compared with CT-guided percutaneous lung nodule biopsy in adults requiring diagnostic evaluation of a pulmonary nodule. The co-primary objectives are to assess non-inferiority of diagnostic efficacy and superiority of safety. The primary endpoints are diagnostic efficacy and the rate of peri-procedural pneumothorax (with or without intervention) associated with the assigned biopsy approach. Eligible participants will be randomized 1:1 to either ssRAB with CBCT or CT-guided percutaneous lung nodule biopsy. If the clinical team determines that the assigned procedure is not suitable, the participant will receive the most appropriate standard of care instead. Both biopsy procedures will be performed according to routine clinical practice, and no experimental devices or procedures will be used. Participants will be followed for up to 12 months through medical record review and routine clinical follow-up. Patient-reported quality of life and, optionally, work status will be assessed using questionnaires at multiple time points. No research-specific assessments, burdensome tests, or advanced imaging outside of standard care will be performed. A chest X-ray will be required following the biopsy procedure, consistent with routine clinical practice.
Interventions
PROCEDUREShape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
A bronchoscopic lung nodule biopsy procedure performed using shape-sensing robotic-assisted bronchoscopy with cone-beam CT guidance as clinically indicated and according to standard clinical practice.
PROCEDURECT-guided percutaneous lung nodule biopsy
A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
Sponsors
Intuitive Surgical
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
1. Patient is aged 18 years or older at time of consent. 2. Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent). 3. Target pulmonary nodule ≤2 cm in largest diameter. 4. Patient is willing and able to give written informed consent for clinical study participation.
Exclusion criteria
1. Patient has previously undergone a biopsy procedure of the target nodule by any approach. 2. Patient was previously randomized in this study but did not undergo biopsy. 3. Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results. 4. Patient is pregnant or breastfeeding as determined by standard site practices. 5. Patient lacks the capacity to provide informed consent for themselves, or is a vulnerable patient whose ability to protect their own interests or to consent freely may be diminished, including but not limited to, patients who may be unduly influenced through dependency on the sponsor, the hospital, or the study doctor. 6. Patient is not willing to comply with study participation requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Efficacy of the Assigned Biopsy Procedure | At the index procedure | Diagnostic efficacy will be calculated as the proportion of patients who receive their assigned treatment multiplied by diagnostic yield of their assigned treatment. |
| Peri-Procedural Pneumothorax Rate | From procedure to 7 days (or until subsequent intervention, whichever occurs first). | Rate of peri-procedural pneumothorax related to the assigned index biopsy procedure, including pneumothorax identified on routine post-procedure imaging and clinically relevant pneumothorax requiring intervention or escalation of care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield | At the index procedure | Diagnostic yield of the index biopsy procedure, defined according to American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) guidance |
| Sensitivity for Malignancy | Through 1 year post-procedure | Sensitivity of the index biopsy procedure for the diagnosis of malignancy, based on final diagnosis established through 1-year follow-up |
| Negative Predictive Value | Through 1 year post-procedure | Negative predictive value of the index biopsy procedure based on final diagnosis established through 1-year follow-up |
| Diagnostic accuracy | Through 1 year post-procedure | Diagnostic accuracy of the index biopsy procedure based on final diagnosis established through 1-year follow-up. |
| Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing | At the index procedure | Proportion of biopsy specimens considered adequate for molecular profiling and/or immunohistochemistry (IHC) testing. |
| Procedure-Related Adverse Events | Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first | Incidence of procedure-related adverse events. |
| Procedure-related serious adverse events. | Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first | Incidence of procedure-related serious adverse events. |
| All-Cause Mortality | Through study exit | Incidence of all-cause mortality among study participants. |
| Length of Stay for Procedure-Related Adverse Events | From the date of hospitalization for a procedure-related adverse event until hospital discharge, for events occurring up to 30 days following the index procedure | Duration of hospitalization attributable to procedure-related adverse events |
Countries
Switzerland, United Kingdom
Contacts
CONTACTCarine Van den Abeele
CONTACTMartha Bean
PRINCIPAL_INVESTIGATORRicky Thakrar, MD
University College London Hospitals
PRINCIPAL_INVESTIGATORNeal Navani, MD
University College London Hospitals
Outcome results
None listed