Reliability and accuracy of a novel classification system using peroral cholangioscopy for the diagnosis of bile duct lesions

Abstract

Background The aim of this study was to propose a novel, comprehensive, macroscopic classification for bile duct lesions.

Methods A two-stage protocol was designed. In Stage I, a retrospective study (September 2013 to September 2015) of patients with bile duct lesions detected by peroral cholangioscopy (POCS) was performed. A total of 315 images with at least 6 months of follow-up were recorded, analyzed, and correlated to histology, and were classified as non-neoplastic (one of three types, 1 – 3) or neoplastic (one of four types, 1 – 4) based on morphological and vascular patterns. In Stage II, a prospective, nonrandomized, double-blind study was performed from December 2015 to December 2016 to validate the proposed classification. Sensitivity, specificity, positive and negative predictive values (PPV and NPV, respectively), and positive and negative likelihood ratios (LR + and LR – , respectively) were calculated (gold standard: 6-month follow-up). Inter- and intraobserver agreement (kappa value, κ) among experts and non-experts were calculated.

Results 171 patients were included (65 retrospective; 106 prospective). In Stage I, 28/65 cases were neoplastic and 37 /65 were non-neoplastic, according to the final diagnosis. In Stage II, 56/106 were neoplastic with a sensitivity, specificity, PPV, NPV, LR + , and LR – for neoplastic diagnosis of 96.3 %, 92.3 %, 92.9 %, 96 %, 12.52, and 0.04, respectively. The proposed classification presented high reproducibility among observers, for both neoplastic and subtypes categories. However, it was better for experts (κ > 80 %) than non-experts (κ 64.7 % – 81.9 %).

Conclusion The novel classification system could help physicians to distinguish non-neoplastic from neoplastic bile duct lesions.

• References

• 1 Draganov PV, Lin T, Chauhan S. et al. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc 2011; 73: 971-979
• 2 Chen YK, Parsi MA, Binmoeller KF. et al. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones. Gastrointest Endosc 2011; 74: 805-814
• 3 Draganov PV, Chauhan S, Wagh MS. et al. Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study. Gastrointest Endosc 2012; 75: 347-353
• 4 Sethi A, Shah RJ, Itoi T. et al. Defining imaging criteria for indeterminate biliary strictures utilizing video cholangioscopy: the Monaco classification. Gastrointest Endosc 2015; 81: AB188-189
• 5 Kalaitzakis E, Webster GJ, Oppong KW. et al. Diagnostic and therapeutic utility of single-operator peroral cholangioscopy for indeterminate biliary lesions and bile duct stones. Eur J Gastroenterol Hepatol 2012; 24: 656-664
• 6 De Bellis M, Sherman S, Fogel EL. et al. Tissue sampling at ERCP in suspected malignant biliary strictures (part 1). Gastrointest Endosc 2002; 56: 552-561
• 7 Kim HJ, Kim MH, Lee SK. et al. Tumor vessel: a valuable cholangioscopic clue of malignant biliary stricture. Gastrointest Endosc 2000; 52: 635-638
• 8 Seo DW, Lee SK, Yoo KS. et al. Cholangioscopic findings in bile duct tumors. Gastrointest Endosc 2000; 52: 630-634
• 9 Tang D, Nagano H, Yamamoto H. et al. Angiogenesis in cholangiocellular carcinoma: expression of vascular endothelial growth factor, angiopoietin-1/2, thrombospondin-1 and clinicopathological significance. Oncol Rep 2006; 15: 525-532
• 10 Navaneethan U, Hasan MK, Lourdusamy V. et al. Single-operator cholangioscopy and targeted biopsies in the diagnosis of indeterminate biliary strictures: a systematic review. Gastrointest Endosc 2015; 82: 608-614
• 11 Manta R, Frazzoni M, Conigliaro R. et al. SpyGlass single-operator peroral cholangioscopy in the evaluation of indeterminate biliary lesions: a single-center, prospective, cohort study. Surg Endosc 2013; 27: 1569-1572
• 12 Siddiqui AA, Mehendiratta V, Jackson W. et al. Identification of cholangiocarcinoma by using the Spyglass Spyscope system for peroral cholangioscopy and biopsy collection. Clin Gastroenterol Hepatol 2012; 10: 466-471
• 13 Nishikawa T, Tsuyuguchi T, Sakai Y. et al. Comparison of the diagnostic accuracy of peroral video-cholangioscopic visual findings and cholangioscopy-guided forceps biopsy findings for indeterminate biliary lesions: a prospective study. Gastrointest Endosc 2013; 77: 219-226
• 14 Sun X, Zhou Z, Tian J. et al. Is single operator peroral cholangioscopy a useful tool for the diagnosis of indeterminate biliary lesion? A systematic review and meta-analysis. Gastrointest Endosc 2015; 82: 79-87
• 15 Woo YS, Lee JK, Oh SH. et al. Role of SpyGlass peroral cholangioscopy in the evaluation of indeterminate biliary lesions. Dig Dis Sci 2014; 59: 2565-2570