New-gen robotic bronchoscopy safe, effective for peripheral pulmonary lesions

A second-generation robotic electromagnetic navigation (EMN) bronchoscopic platform combined with integrated digital tomosynthesis (DT) demonstrates acceptable safety and high diagnostic yield for small peripheral lung nodules, results of the first-in-human study have shown.

“There was a high rate of success at reaching the lesion, demonstrating tool-in-lesion in all cases and an overall yield of 94.7 percent,” the investigators said.

This clinical trial of a new robotic bronchoscopy included 18 patients with moderate-risk peripheral pulmonary nodules (n=19), with an average lesion size of 20 mm and average distance from the pleura of 11.6 mm.

The investigators performed robotic bronchoscopy using EMN with tool-in-lesion tomosynthesis-assisted lesion guidance. They followed up nonspecific results until either a clear diagnosis was achieved or repeat radiology at 6 months showed stability.

The target was successfully reached in all 19 nodules (100 percent). The biopsy tool was also visualized inside the target lesion in all patients. [Respirology 2024;29:969-975]

Seventeen nodules had a confirmed specific diagnosis, of which 13 were malignant. Radiological monitoring in one patient confirmed a true nonmalignant result. These results represented a yield of 89.5 percent (strict) to 94.7 percent (intermediate).

In terms of safety, pneumothorax occurred in two patients, one requiring observation only and the other an overnight chest drain. Another patient developed severe pneumonia following the procedure.

Successful biopsy

Six variables are necessary for a successful bronchoscopic lung nodule biopsy, namely successful navigation, ability to reach, real-time imaging, appropriate biopsy tools, confidence in sampling, and appropriate specimen handling and processing. [Curr Oncol 2012;19(Suppl 1):S16-S23; J Thorac Dis 2020;12:7683-7690]

“In order to increase the yield of bronchoscopic lung nodule biopsy and bridge the yield gap with that of transthoracic CT-guided biopsy, one needs to think beyond improvement in these domains individually and instead focus on combining these improvements, ideally integrating them into one system,” according to the investigators.

The new system assessed in this study “successfully integrates accessible three-dimensional imaging with EMN in a robotic platform that provides reach, stability, and vision,” they added. [Lung 2023;201:85-93]

Sampling error

The discrepancy between the 100-percent rate of placing the biopsy tool in the lesion and the <100-percent diagnostic yield also exists in previous studies. This potentially suggests a sampling error or density and distribution of tumour cells within the nodule. Another possible reason is the choice of biopsy tool and specimen handling and processing. [J Clin Med 2021;10:5678]

“Overall, tool-in-lesion imaging is an advancement that not only improves yield but also increases one's confidence in nonmalignant biopsy results,” the investigators said. “This increased confidence has real and important clinical consequences for patients, as it could prevent unnecessary and often futile follow-up procedures.” [J Thorac Dis 2020;12:3272-3278]

“Larger prospective multicentre studies are required to further clarify the yield and safety profile of this robotic platform,” according to the investigators.