A Randomized Comparative Study of the Use of Individual Modality and Combination of Endoscopic Retrograde Cholangiopancreatography (ERCP) and Digital Single-Operator Cholangioscopy (DSOC) for Diagnosis of Indeterminate Biliary Strictures.

ABSTRACT

Background: To determine the superiority of the combination of endoscopic retrograde cholangiopancreatography (ERCP) and digital single-operator cholangioscopy (DSOC) in the same sitting over the individual modality alone in patients with indeterminate biliary strictures. Materials and Methods: A randomized study enrolled 60 adult patients with biliary strictures who were randomized into two groups ERCP + DSOC and ERCP/DSOC. Histopathologic or cytologic assessment was performed in terms of benign, indeterminate, or malignant nature of the strictures. Procedural adverse events were documented. Accuracy in terms of sensitivity (Sn), specificity (Sp), and predictive value [positive (PPV) and negative (NPV)] were noted. Results: As per final diagnosis, in ERCP/DSOC group, there were 12 (40%) benign cases and 18 (60%) malignant cases, and in group ERCP + DSOC, there were 8 (26.67%) benign cases and 22 (73.33%) malignant cases. ERCP/DSOC labeled 16 (53.33%) patients as benign, 8 (26.67%) as malignant, and 6 (20%) as indeterminate, while ERCP + DSOC labeled 8 (26.67%) as benign, 17 (56.67%) as malignant, and 5 (16.67%) as indeterminate. The Sn, Sp, PPV, and NPV of ERCP/DSOC were 44.4%, 75%, 100%, and 56.25%, and for ERCP + DSOC was 77.27%, 62.50%, 100%, and 62.5%, respectively (P = 0.033). Side effects were statistically similar in both the groups (P > 0.05). Conclusion: To conclude, the combination of ERCP with DSOC is safe and effective with higher diagnostic sensitivity (77.27%) in comparison to standard ERCP or DSOC alone (44.4%) for the diagnosis of biliary strictures.