Junjie Mi, Digestive Endoscopy Center, Shanxi Provincial People’s Hospital, China.

•The present study will perform a meta-analysis to assess the accuracy of pCLE in diagnosing indeterminate biliary strictures and to compare the accuracy of pCLE and ERCP with brush cytology and intraductal biopsy in diagnosing indeterminate biliary strictures.

•To evaluate the accuracy of pCLE and tissue sampling by ERCP in the diagnosis of indeterminate biliary strictures, 18 articles were included from 2008 to 2021 through Embase, PubMed, Web of Science, and Cochrane library databases.

•The summary estimates for the pCLE diagnosis of indeterminate biliary strictures were: sensitivity 0.88 (95% confidence interval (CI), 0.84–0.91); specificity 0.79 (95% CI 0.74–0.83); and Diagnostic Odds Ratio (DOR) 24.63 (95% CI 15.76–38.48). The summary estimates for tissue sampling by ERCP diagnosis for indeterminate biliary strictures were: sensitivity 0.54 (95% CI 0.49–0.59); specificity 0.96 (95% CI 0.94–0.98); and DOR 11.31 (95% CI 3.90–32.82). The area under the sROC curve of pCLE diagnosis of indeterminate biliary strictures is 0.90 higher than 0.65 of tissue sampling by ERCP.

•The pCLE is a better approach than tissue sampling by ERCP for the diagnosis of indeterminate biliary strictures by providing real-time microscopic images of the bile ducts.