Use of Spyglass® Direct Visualization for the Extraction of Cystic Duct Stones

Abstract

Purpose: The Spyglass® Direct Visualization System (Boston Scientific) is a single operator system used to directly visualize the bile ducts and allows lithotripsy and biopsies under direct intra-luminal view. Spyglass has been increasingly utilized for difficult to extract cystic duct stones. Little data exists regarding its safety and efficacy for this purpose. The aim of this study was to determine if Spyglass is effective and safe for the extraction of cystic duct stones. Methods: We undertook a retrospective study evaluating all ERCPs performed using the Spyglass system for treatment of cystic duct stones from Oct 2005-Jan 2010 at our institution. We collected data on patient demographics, procedure indications, success, and complications. Primary outcomes were complete cystic duct clearance on first attempt and procedural complications. The secondary outcome was final duct clearance regardless of the number of attempts. Results: A total of 17 procedures in 14 patients were identified where ERCP with Spyglass was used for previously identified cystic duct stones. All patients had stones that were not amenable to extraction via traditional ERCP. The mean age was 57 +/- 18 yrs and 57% were female. Most patients were referred for Spyglass with abdominal pain and cystic duct stone identified on imaging or ERCP. Of the 17 procedures, 12 were done under conscious sedation or monitored anesthesia care and 5 were under general anesthesia. The mean procedure duration was 58.8 +/- 28.7 min. The median stone size was 8 mm (range 4 to 30 mm). In 1 patient, the cystic duct stone was no longer present at the time of Spyglass. Of the remaining 13 patients, complete cystic duct clearance on first attempt was achieved in 6 patients (46.2%). Two additional patients had successful cystic duct clearance after a second procedure. Thus complete duct clearance was achieved in a total of 8 patients (61.5%). Of the remaining 5/13 patients, 1 had partial extraction, while 4 had failed extraction. Reasons for failed extraction were impacted cystic duct stone (1), multiple CBD/cystic duct stones (1), tortuous cystic duct (1), and patient intolerance of the procedure (1). Two patients with failed extraction went on to surgical treatment, 1 had a clear cystic duct on repeat Spyglass, and 1 was lost to follow-up. There were no procedural or anesthesia related complications with Spyglass except for mild nausea and tachycardia in 1 patient. Conclusion: The Spyglass Direct Visualization System is safe and effective for the management of cystic duct stones. If available, Spyglass should be considered the procedure of choice in patients with failed cystic duct stone extraction during traditional ERCP. Disclosure: Sirish Sanaka MD - Stockholder (owns few stocks): Boston Scientific; Douglas Pleskow MD - Consultant: Boston Scientific; Ram Chuttani MD - Received educational grant support: Boston Scientific.