Abstract
Background
Digital single‐operator cholangioscopy (DSOC) (SpyGlass DS™, Boston Scientific, MA, USA) allows for high‐definition imaging of the biliary tree. The superior visualization has led to the development of two different sets of criteria to evaluate and classify indeterminate biliary strictures: the Monaco criteria and the criteria in Carlos Robles–Medranda’s publication (CRM). Our objective was to assess the interrater agreement (IA) of DSOC interpretation for indeterminate biliary strictures using the two newly published criteria.
Methods
Forty de‐identified DSOC video recordings were sent to 15 interventional endoscopists with experience in cholangioscopy. They were asked to score the videos based on the presence of Monaco Classification criteria: stricture, lesion, mucosal changes, papillary projections, ulceration, white linear bands or rings, and vessels. Next, they scored the videos using CRM criteria: villous pattern, polypoid pattern, inflammatory pattern, flat pattern, ulcerate pattern and honeycomb pattern. The endoscopists then diagnosed the recordings as neoplastic or non-neoplastic based on the criteria. Intraclass correlation (ICC) analysis was done to evaluate interrater agreement for both criteria set and final diagnosis.
Results
Recordings of 26 malignant lesions and 14 benign lesions were scored. The IA using both the Monaco criteria and CRM criteria ranged from poor to excellent (range 0.1–0.76) and (range 0.1–0.62), respectively. Within the Monaco criteria, IA was excellent for lesion (0.75) and fingerlike papillary projections (0.74); good for tortuous vessels (0.7), mucosal features (0.62), uniform papillary projections (0.53), and ulceration (0.58); and fair for white linear bands (0.4). Within the CRM criteria, the IA was good for villous pattern (0.62), flat pattern (0.62), and honeycomb pattern; fair for ulcerated pattern (0.56), polypoid pattern (0.52) and inflammatory pattern (0.54). The diagnostic IA using Monaco criteria was good (0.65), while the diagnostic IA using CRM was fair (0.58). The overall diagnostic accuracy using the Monaco classification was 61% and CRM criteria were 57%.
Conclusion
The IOA and accuracy rate of DSOC using visual criteria from both Monaco Criteria and CRM are similar. However, some criteria from both sets suffer from poor IA, thus affecting the overall diagnostic accuracy. More formal training and refinements in visual criteria with additional validation are needed to improve diagnostic accuracy.
Trial Registration
ClinicalTrials.gov Identifier: NCT02166099.
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Amy Tyberg: Consultant for Ninepoint Medical, Endogastric Solutions, Obalon Therapeutics. She is a director of Therapeutic Endoscopic Ultrasound society. Adam Slivka, Divyesh Sejpal, Raj Shah: Consultant for Boston Scientific and Olympus Medical. Douglas G Adler: Consultant for Boston Scientific. Isaac Raijman: Speaker for Boston Scientific, ConMed, Medtronic and GI Supplies. He is on the advisory board of Microtech. And he is a coowner of EndoRx. Paul Tarnasky, Prashant Kedia: Consultant and speaker for Boston Scientific. Michel Kahaleh: Consulting work for Boston Scientific, Interscope Med, ERBE, Medrobotic and AbbVie. He has received research grants from Boston Scientific, Conmed, Pinnacle, Cook, Gore, Merit, and Olympus. He is the CEO and Founder of Innovative Digestive Health Education & Research Inc., and Therapeutic Endoscopic Ultrasound Society. Monica Gaidhane: Consulting work for Interscope Med and Capvision. She is the COO of Therapeutic Endoscopic Ultrasound Society and Innovative Digestive Health Education & Research Inc. Avik Sarkar: Director of Obesity Coalition Inc. The remaining authors declare that they have nothing to disclose.
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This project was presented as a poster at United European Gastroenterology (UEG) Week 2019 Vienna.
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Kahaleh, M., Raijman, I., Gaidhane, M. et al. Digital Cholangioscopic Interpretation: When North Meets the South. Dig Dis Sci 67, 1345–1351 (2022). https://doi.org/10.1007/s10620-021-06961-z
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DOI: https://doi.org/10.1007/s10620-021-06961-z