Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates

Abstract

Background Peroral cholangioscopy (POCS) can be useful for difficult bile duct stone clearance. Large prospective multinational data on POCS-guided lithotripsy for clearing difficult bile duct stones in a single session of endoscopic retrograde cholangiopancreatography (ERCP) are missing. Methods Patients with difficult bile duct stones (defined as one or more of: largest stone diameter ≥ 15 mm, failed prior attempt at stone clearance, impacted, multiple, hepatic duct location, or located above a stricture) were enrolled at 17 centers in 10 countries. The principal endpoint was stone clearance in a single ERCP procedure using POCS. Results 156 patients underwent 174 sessions of POCS-guided electrohydraulic or laser lithotripsy. Stone clearance had failed in a previous ERCP using traditional techniques in 124/156 patients (80 %), while 32 /156 patients (21 %) were referred directly to POCS-guided therapy based on preprocedural assessment of the difficulty of stone clearance. In 101/156 patients (65 %), there were impacted stones. POCS-guided stone clearance was achieved in a single POCS procedure in 125 /156 patients (80 %, 95 % confidence interval [CI] 73 % – 86 %), and was significantly more likely for stones ≤ 30 mm compared with > 30 mm (odds ratio 7.9, 95 %CI 2.4 – 26.2; P = 0.002). Serious adverse events occurred in 3/156 patients (1.9 %, 95 %CI 0.4 % – 5.5 %), and included pancreatitis, perforation due to laser lithotripsy, and cholangitis (n = 1 each), all resolved within 1 week. Conclusion POCS-guided lithotripsy is highly effective for clearance of difficult bile duct stones in a single procedure and successfully salvages most prior treatment failures. It may also be considered first-line therapy for patients with difficult choledocholithiasis to avoid serial procedures.

Using single-operator cholangioscopy for endoscopic evaluation of indeterminate biliary strictures: results from a large multinational registry

“…In four patients, stones were found during their procedure for indeterminate biliary stricture. Data for these four patients were included in both the current study and a previous SpyGlass AMEA registry study of cholangioscopy-guided lithotripsy for difficult bile duct stone clearance [7].…”

“…Since then a prospective, multicenter study was completed in the Asia, Middle East, and Africa (AMEA) regions and included 522 patients who underwent POCS for various indications, including biliary stone disease, as well as indeterminate biliary strictures. The outcomes of a subcohort of this study with difficult biliary stone disease were recently published [7].…”

Cracking Difficult Biliary Stones

“…27 Data from a large multinational registry demonstrated that a larger size of the largest stone and a higher number of stones had a negative impact on the rate of complete stone clearance in a single session. 28 Cholangioscopy-guided lithotripsy is superior to other methods, including ML or EPLBD, because it can be used as a rescue method after the failure of ML or EPLBD, and is a good alternative to common bile duct (CBD) exploration. Buxbaum et al reported that SOC-guided LL provided a higher stone clearance rate in > 10-mm stones than the conventional methods, including ML and balloon sphincteroplasty (93% vs. 67%, p= 0.009), in a randomized study.…”

The Expansion of Cholangioscopy: Established and Investigational Uses of SpyGlass in Biliary and Pancreatic Disorders

“…Overall, the group found that cholangioscopy allowed for direct visualization of stones in 100% of patients, and that stone clearance was successful in a single SOC procedure for 80% of cases. The stones were cleared using either electrohydraulic or laser lithotripsy, with no significant difference in outcomes between the two (74% vs. 82%) The use of SpyGlass also had a significant impact on patient management, leading to a change in diagnosis or therapy in 91% of patients, including 83 patients who no longer needed surgical stone removal [14].…”

“…Direct visual inspection of bile duct strictures may help the determination of benign versus malignant stricture and may also allow for targeted and accurate tissue biopsy ( Figure 2). difference in outcomes between the two (74% vs. 82%) The use of SpyGlass also had a significant impact on patient management, leading to a change in diagnosis or therapy in 91% of patients, including 83 patients who no longer needed surgical stone removal [14].…”