Efficacy and Safety of Digital Single-Operator Cholangioscopy in the Diagnosis of Indeterminate Biliary Strictures by Targeted Biopsies: A Systematic Review and Meta-Analysis

Abstract

Background: Biliary strictures are frequently encountered in clinical practice. The determination of their nature is often difficult. This study aims to systematically evaluate the efficacy and safety of the second generation of digital single-operator cholangioscopy (SpyGlass DS, DSOC) in indeterminate biliary strictures (IBDS) through biopsies. Methods: All relative studies published in Medline, the Cochrane Library, Web of Science, and EMBASE were included. The diagnostic tests for IBDS were compared to the surgical histology, autopsy, or long-term clinical follow-up. The methodological quality of the included studies was evaluated by the Quality Assessment of Studies of Diagnostic Accuracy Included in Systematic Reviews (QUADAS-2). Results: A total of 11 studies, which involved 356 patients diagnosed through biopsies, were included. The pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio 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), respectively. The area under the curve (AUC) was 0.9479, and the pooled adverse event rate was 7%. The sensitivity and specificity in the heterogeneity analysis were I2 = 48.1% and I2 = 25.4%, respectively. Conclusion: SpyGlass DS is a safe and effective technique for IBDS. However, future randomized trials are needed to determine optimal number of biopsies.

Clinical Outcomes of Digital Cholangioscopy-Guided Procedures for the Diagnosis of Biliary Strictures and Treatment of Difficult Bile Duct Stones: A Single-Center Large Cohort Study

“…However, the accurate visual diagnosis of biliary strictures and assessment of the extent of a lesion are not possible by ERCP, and treatment of bile duct stones by ERCP procedures is sometimes difficult. Peroral cholangioscopy (POCS) has recently become a useful modality for diagnostic and therapeutic procedures in patients with biliary diseases [ 1 , 2 ]. POCS enables direct visualization of the biliary tract and the sampling of suspicious lesions, together with lithotripsy with electrohydraulic lithotripsy (EHL) or laser lithotripsy.…”

Choledochoscopy: An update

“…IBS is defined as biliary strictures with aetiologies that cannot be established after standard diagnostic investigations such as laboratory tests, imaging (such as computed tomography or magnetic resonance cholangiopancreatography), or procedures (such as endoscopic retrograde cholangiopancreatography (ERCP)-guided tissue biopsy)[ 40 ]. This section will discuss the role of choledochoscopy in diagnosing IBS, specifically when along with the diagnostic algorithm it should be done, optimal choledochoscope choice, the two main ways choledochoscopy can be used, and factors affecting its diagnostic accuracy.…”

“…Direct visualization by choledochoscopy permits the identification of mucosal features suspicious for malignancy and targeted biopsies. In a recent meta-analysis by Wen et al [ 40 ] involving 356 patients across 11 studies, the visual impression was more sensitive than choledochoscopy-guided biopsy across DSOC, FSOC, and D-POC (95% vs 74%, 84.5% vs 60.1%, 83%-92% vs 43%-89.5%). However, specificity was higher in choledochoscopy-guided biopsy than visual impression across DSOC, FSOC and D-POC (98% vs 92%, 98% vs 82.6%, 97% vs 84%-92%)[ 40 ].…”

Tips and tricks for the diagnosis and management of biliary stenosis-state of the art review

“…The diagnostic accuracy of D-SOC is further improved by D-SOC-guided biopsy, which allows precise tissue sampling of the detected lesions. In a meta-analysis by Wen et al [ 43 ], SpyBite (Boston Scientific) biopsy showed a pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio of 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), with a lower complication rate mainly ERCP-related. Acute cholangitis was the most common complication with a rate of 1.8%[ 43 ].…”

“…A point of great debate is the number of biopsies needed to obtain adequate tissue for a diagnostic histopathological assessment. Based on currently available studies, the number of biopsies is not defined with any certainty, but more than two biopsies are required to reach a sensitivity > 70%[ 23 , 43 ]. In a randomized multicenter investigation, an average of six biopsy specimens were taken during POCS, achieving a sensitivity of 68.2%, which increased up to 95.5% if visual impression at cholangioscopy was added to biopsy forceps performance[ 41 ].…”