Single-Operator Cholangioscopy-Guided Electrohydraulic Lithotripsy for Difficult Common Bile Duct Stones: A Prospective Cohort Study of Efficacy, Safety, and Clinical Outcomes

Abstract

Background: Difficult common bile duct (CBD) stones, characterized by a diameter exceeding 15 mm, impaction, multiple stone burden, or associated biliary strictures, constitute 10–15% of endoscopic retrograde cholangiopancreatography (ERCP) cases and often resist conventional extraction. The application of single-operator cholangioscopy (SOC)–based electrohydraulic lithotripsy (EHL) has shown positive results as an advanced treatment method, although its real-world effectiveness needs further exploration in settings that lack resources. The researchers conducted a prospective study to assess the safety and effectiveness of SOC-based EHL treatment for patients with difficult CBD stones who did not respond to standard ERCP methods.

Methods: The researchers conducted a prospective single-arm cohort study at Al-Azhar University Hospitals, which started in November 2023 and ended in July 2024 after they enrolled 25 consecutive patients who had failed standard extraction methods for difficult CBD stone removal. The patients received SOC-guided EHL treatment through the SpyGlass system, which enabled them to retrieve stone fragments using either balloon sweepers or Dormia baskets. The primary outcome tracked complete stone clearance through occlusion cholangiography, while the secondary outcomes measured three different factors, which included procedural success, assessment of ERCP sessions, and complication rates.

Results: The study enrolled 25 patients who consisted of 14 females and 11 males with an average age of 61.8 years and a standard deviation of 6.4 years. The study found that the mean largest stone diameter measured 15.6 mm with a standard deviation of 3.3 mm, while 14 patients (56.0%) had multiple stones and 15 patients (60.0%) had stones that exceeded 15 mm in size. The study achieved complete ductal clearance for 22 patients (88.0%) while performing balloon extraction in 22 cases (88.0%) and using controlled radial expansion balloon dilation as an adjunct in five cases (20.0%). The study found no major complications, which included post-ERCP pancreatitis, bleeding, and perforation.

Conclusion: The SOC-guided EHL system achieves high success rates through 88.0% stone elimination while maintaining a safe operational record, which enables its use as a primary treatment method for complex endoscopic procedures that decrease the need for surgical or percutaneous methods.