When diagnosing indeterminate biliary strictures, digital single-operator cholangioscopy (DSOC)-guided biopsy has demonstrated safety, efficacy, and higher sensitivity than standard endoscopic retrograde cholangiopancreatography (ERCP), according to a study recently published in Gastrointestinal Endoscopy.

This prospective multicenter trial included 61 final participants with biliary obstructive symptoms and indeterminate biliary stricture suspected to be located proximal to the distal common bile duct. Participants were randomly assigned to either the study arm (n=32) for DSOC visualization and biopsy or the control arm (n=29) for standard ERCP visualization with tissue brushing. The primary end point was diagnostic accuracy of the technique at 6 months; strictures were considered benign if no malignancy was confirmed by 6 months. A Mann-Whitney U test was used to examine differences between groups.

48.2% (n=14/29) developed malignancy in the control arm, while 68.8% (n=22/32) developed malignancy in the study arm. Whereas no significant differences were observed between DSOC-guided biopsies and ERCP-guided brushing in terms of specificity, positive predictive value, negative predictive value, or overall accuracy, DSOC-guided biopsies had a significantly higher sensitivity (68.2% vs 21.4%, respectively; P <.01). Visual impression affected patient management in 56.7% of the study arm compared with 50% of the control arm (P =.62). The sensitivity of visualization was higher in the study arm vs the control arm (95.5% vs 66.7%, respectively; P =.02), as was overall accuracy (87.1% vs 65.5%; P =.05). Visualization and biopsy were significantly related in the study arm (P =.02). Both arms experienced a low rate of adverse events and no serious adverse events.


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Limitations to this study included a small sample size, slight imbalances to cohort numbers, a lack of central assessment or intersite comparison of histopathological or cytological analysis, a potential lack of generalizability, and a lack of analysis of cost-effectiveness.

The researchers concluded that “DSOC was shown to be safe and effective with a higher diagnostic sensitivity compared with standard ERCP and brushing for the diagnosis of indeterminate biliary strictures.” They further noted that the visual elements of DSOC demonstrated a “pertinent impact on patient management and should be an essential part of determining the correct diagnosis.…DSOC should be considered as a viable diagnostic alternative to conventional ERCP for indeterminate biliary strictures.”

Reference

Gerges C, Beyna T, Tang RSY, et al. Digital single-operator peroral cholangioscopy-guided biopsy versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized multicenter trial (with video) [published online November 25, 2019]. Gastrointest Endosc. doi: 10.1016/j.gie.2019.11.025