Abstract
OBJECTIVES: Cholangioscopy-guided mapping biopsy (CMB) is performed for preoperative evaluation of extrahepatic cholangiocarcinoma. The aim of this study was to evaluate the usefulness of CMB using a SpyBite Max and to determine the effectiveness of multiple biopsy strokes from the same site. METHODS: Between August 2020 and October 2022, 21 patients with extrahepatic cholangiocarcinoma were enrolled in this prospective observational study. The primary outcome was the rate of site-based successful biopsies, which was defined as the acquisition of epithelium-containing material appropriate for diagnosing benignity/malignancy from each site. The cumulative success rate of obtaining appropriate materials increased by increasing biopsy strokes from 1 to 4. RESULTS: The cholangioscope could be advanced to all 80 target sites. The overall adequate specimen rate was 67% (142/212). The overall rate of site-based successful biopsies was 83% (66/80). The cumulative success rate of obtaining appropriate materials did not significantly improve by increasing the number of biopsy strokes from 1 (81%) to 4 (86%). CONCLUSIONS: The biopsy material was obtained for 83% of the required sites. However, repetitive biopsy strokes for the same site did not improve the rate of site-based successful biopsy. This study was registered in UMIN (UMIN000041530).