Percutaneous transhepatic cholangioscopy using a single-operator cholangioscope (pSOC), a retrospective, observational, multicenter study.

BACKGROUND AND AIMS: Percutaneous cholangioscopy (PC) is more complex and invasive than a transpapillary approach, with the need for a large percutaneous tract of 16 French (Fr) on average in order to advance standard percutaneous cholangioscopes. The aim of this study was to investigate whether percutaneous single-operator cholangioscopy (pSOC) using the SpyGlass™ DS system is feasible, safe, and effective in PC for diagnostic and therapeutic indications. MATERIALS AND METHODS: The data of 28 patients who underwent pSOC in 4 tertiary referral centers were retrospectively analyzed. Technical and clinical success for therapeutic procedures was assessed as well as diagnostic accuracy of pSOC-guided biopsies and visualization. Adverse events and the required number and size of dilatations were reviewed. RESULTS: 25/28 (89%) patients had a post-surgical altered anatomy. The average number of percutaneous dilatations prior to pSOC was 1.25 with a mean dilatation size of 11 French. Histopathology showed a 100% accuracy. Visual impression showed an overall accuracy of 96.4%. Technical and clinical success was achieved in 27/28 (96%) of cases. Adverse events occurred in 3/28 (10.7%) cases. CONCLUSION: pSOC is a feasible, safe, and effective technique for diagnostic and therapeutic indications. It may be considered an alternative approach in clinical cases where gastrointestinal anatomy is altered. It has the potential to reduce peri-procedural adverse events and costs. Prospective randomized-controlled trials are necessary to confirm the previously collected data.

Diagnostic and therapeutic single-operator cholangiopancreatoscopy with SpyGlassDS™: results of a multicenter retrospective cohort study.

BACKGROUND AND AIMS: The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™. METHODS: In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months. RESULTS: Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001). CONCLUSIONS: SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.