Peroral Cholangioscopy Guided Stone Therapy - Report of An International Multicenter Registry

Abstract

Background: Peroral cholangioscopy has been used for management of biliary stones that cannot be removed by conventional methods. The need for two expert operators and technical limitations of cholangioscopes has hampered their widespread adoption for the management of difficult-to-remove biliary stones. SpyGlass Direct Visualization System (SGDVS) (Boston Scientific, Natick, USA) is a single operator peroral cholangioscope with 4 way tip deflection that recently became commercially available. Aims: Evaluate the efficacy and safety of SGDVS for treatment of difficult-to-remove biliary stones and assess the utility of this device for detection of missed stones by endoscopic retrograde cholangiography (ERC). Methods: 49 patients had cholangioscopy guided stone therapy using SGDVS. These patients reflect 34% (49/146) of the cases in a multicenter open-label cholangioscopy registry involving 15 tertiary care centers in the United States and Europe in which each patient undergoes ERC immediately followed by cholangioscopy. Procedural indications were bile duct stones not amenable to removal by conventional methods or missed by ERC. Procedural success was defined as ability to adequately visualize and initiate stone therapy. All patients had 1 month of follow up after cholangioscopy. Enrollment is ongoing. Results: Stone location was CBD (57%), CHD (22%), IHD (8%), cystic duct (6%), hilum (4%), and LHD (2%). The mean diameter (± SD) of the largest stone in each case was 18 ± 11 mm (range 2-60). In 63% (31/49) of the cases, stones were impacted. In 39% (19/49) of the cases, stones were reported as missed during the ERC immediately preceding the cholangioscopy. Electrohydraulic lithotripsy (EHL) was used in 53% (26/49), laser lithotripsy in 16% (8/49), and conventional methods in 31% (15/49) of the cases. Stones removed by conventional methods were either missed by ERC or required assistance by cholangioscopy for guidewire placement or disimpaction. Procedural success was 92% (45/49) in the group as a whole; 91% (31/34) in the EHL / Laser group; and 93% (14/15) in the conventional group. There were 4 adverse events, 2 related (1 cholangitis and 1 abdominal pain) and 2 unrelated (1 sepsis which was indication for ERC and 1 cholangitis) to ERC / SGDVS procedures. All adverse events resolved without sequela. Conclusions: 1) Peroral cholangioscopy using SGDVS is safe and effective for treatment of difficult-to-remove biliary stones. 2) The rate of missed stones by ERC may be higher than previously reported. Further study is required and ongoing.