RATIONALE
Endobronchial ultrasound (EBUS) combined with a guide sheath (GS) as an instrument for confirming the proximity of the bronchoscope and its relationship to the lesion can increase the diagnostic yield when conducting transbronchial lung biopsy of peripheral pulmonary nodules (PPNs). A novel electromagnetic navigational bronchoscopy (ENB) system comprising a thinner locatable sensor probe as a guidance instrument was developed to be suitable for a thin bronchoscope with a 2-mm-diameter working channel. The diagnostic efficacy of EBUS-GS with or without this ENB system has not been confirmed.
OBJECTIVES
To compare the diagnostic value and safety of EBUS-GS with or without ENB system for diagnosing PPNs.
METHODS
A prospective, multicenter, randomized controlled clinical trial was designed and conducted at 3 centers. Patients with PPNs suspected to be malignant were enrolled and randomly assigned to the ENB-EBUS-GS group or EBUS-GS group. The primary endpoint was the diagnostic yield in each group. The secondary endpoint was the procedural time and other factors affecting diagnostic yield. The safety endpoint was procedural complications.
RESULTS
Four hundred participants were enrolled from July 2018 to October 2019 and 385 patients were analyzed, with 193 in the ENB-EBUS-GS group and 192 in the EBUS-GS group. The mean nodule size was 21.7±5.3 mm. The diagnostic yields were 82.9% (95% confidence interval (CI), 77.6%-88.2%) in the ENB-EBUS-GS group and 73.4% (95% CI, 67.2%-79.7%) in the EBUS-GS group. The difference between the two groups was 9.5% (95% CI, 2.6%-16.3%), with an adjusted difference of 9.0% (95% CI, 2.3%-15.8%), after adjusting for the stratification factors and center. The time for finding lesions in the ENB-EBUS-GS was shorter than that in the EBUS-GS group (213.2±145.6s vs. 264.8±189.5s, p=0.003). And intraoperative hemorrhage occurred 3.6% in the ENB-EBUS-GS group and 3.1% in the EBUS-GS group, without significant differences between the two groups.
CONCLUSIONS
The novel ENB system combined with EBUS-GS demonstrated improved ability to locate PPNs, achieving a high diagnostic yield for PPNs compared to EBUS-GS alone in a safe and efficient procedure. Clinical trial registered with ClinicalTrials.gov (NCT03569306).