Background: Biliary strictures are frequently encountered in clinical practice.It can be caused by benign or malignant diseases.The determination of its nature is often difficult.It often leads to unnecessary surgical treatment or delayed treatment by unclear diagnosis.The new Spyglass DS system,which become available in 2015,has mostly been studied in small clinical trials.This study aims to systematically evaluate the efficacy and safety of digital single-operator cholangioscopy(Spy Glass DS,DSOC)in indeterminate biliary strictures(IBDS).Methods: All relative studies published in Chinese database(Wan Fang database,China knowledge Network database datase,Wei Pu database)and English database(Medline,the Cochrane Library,Web of Science,and EMBASE)and were included.The golden diagnostic standards are surgical histology,autopsy,or long-term clinical follow-up.The methodological quality of the included studies was evaluated by "QUADAS-2".The indicators included sensitivity,specificity,positive likelihood ratio,negative likelihood ratio,diagnostic odds ratio and complications(cholangitis,bile duct perforation,pancreatitis,hyperamylasemia,abdominal pain,fever)Results: A total of 11 studies,which involved 356 patients diagnosed through biopsies and 457 patients through visual impression,were included.The pooled sensitivity,specificity,positive likelihood ratio,negative likelihood ratio and diagnostic odds ratio for biopsies were 0.74(95% CI: 0.67-0.80),0.98(95% CI: 0.95-1.00),10.52(95%CI: 5.45-20.32),0.31(95% CI: 0.23-0.41),and 65.18(95% CI:26.79-158.61),the area under the curve(AUC)was 0.9479.The pooled sensitivity,specificity,positive likelihood ratio,negative likelihood ratio and diagnostic odds ratio for visual impression were0.95(95% CI: 0.91–0.97),0.92(95% CI: 0.88–0.95),9.29(95% CI:5.12–16.86),0.08(95% CI: 0.05-0.14)and 178.24(95% CI:80.10-396.64),the AUC was 0.9774.The pooled adverse event rate was7.0%.Conclusion: Spy Glass DS is a safe and effective technique for IBDS.Spyglass DS has a higher diagnostic accuracy than conventional methods such as ERCP and imaging.However,future randomized trials are needed to determine optimal number of... |