Patients with IDBSs were evaluated by intraprocedural ROSE-TIC during SOC-guided biopsy procedures. Final diagnosis was established by long-term patient follow-up in conjunction with off-site findings or surgical histology. The main outcome measure was to evaluate the utility of ROSE-TIC by determination of its operating characteristics and comparison with off-site histologic assessment.
Of 31 patients with IDBSs, tissue diagnosis was indeterminate at prior ERCP-guided brush and/or biopsy in 14, prior EUS-guided FNA (EUS-FNA) in 6, and a mass could not be identified at EUS in 11. The mean number of biopsies performed was 3.3 (range 1-8), and diagnostic interpretation by ROSE-TIC was diagnostic and/or suspicious for carcinoma in 15, benign in 13, atypical-reactive in 2, and bile duct intraductal papillary mucinous neoplasm in 1. Final diagnosis by surgical histology (n = 4), death by disease (n = 10), and patient follow-up (n = 17) showed that the overall sensitivity of ROSE-TIC for diagnosing malignancy was 100%, specificity 88.9%, positive predictive value 86.7%, negative predictive value 100%, and diagnostic accuracy 93.5%.
Preliminary data suggest that the diagnostic outcomes of SOC-guided biopsies in IDBSs can be significantly improved by using ROSE-TIC. This technique also may benefit centers that rely mainly on fluoroscopy-guided intraductal biopsies.