First in Human Evaluation of a Novel Thin Convex Probe Endobronchial Ultrasound System.

Abstract

The incidence of pulmonary imaging abnormalities continues to increase. While standard CP-EBUS is safe and accurate, it has limited reach through smaller bronchi. Olympus BF-Y0069 TCP-EBUS has smaller diameter and improved angulation. We assessed safety and feasibility of the TCP-EBUS to evaluate lesions not accessible with CP-EBUS. A single-center, prospective, pilot study evaluating TCP-EBUS enrolled patients undergoing bronchoscopy for lesions within the inner two-thirds of the lung. Patients underwent CP-EBUS to attempt visualization and biopsy. If unsuccessful, TCP-EBUS was used. Safety, lesion characteristics, and pathology results were collected. 51 patients were enrolled with multiple lesion locations and no adverse safety events with TCP-EBUS. Seven cases(13.7%) were omitted as the target lesion was visualized by CP-EBUS and TCP-EBUS. CP-EBUS failed to provide biopsy for 44 cases. CP-EBUS visualized 7/44, however, was unable to biopsy. TCP-EBUS visualized 36/44(81.8 %) lesions and biopsied 27/44(61%) lesions. 8/44(15.7%) lesions could not be visualized with either device. Median lesion size biopsied with CP-EBUS was 41mm(IQR 22-48). Median size of lesions visualized with TCP-EBUS was 20mm(IQR 15.3-38), range 8-70. The median distance from the main carina was 62mm(IQR 60-89) for lesions biopsied with the CP-EBUS and 63.3(IQR 48.5-78.8) for TCP-EBUS. While average distances from main carina were similar in both groups, the furthest lesion TCP-EBUS visualized was 120mm from the carina compared to 100mm with CP-EBUS. The use of TCP- EBUS was safe and effective without observed patient-associated complications, and it provided real-time ultrasonographic visualization and biopsy of lesions not accessible with CP-EBUS.