Laser Lithotripsy for Difficult Large Bile Duct Stones
Laser Lithotripsy for Difficult Large Bile Duct Stones
Very large bile duct stones are difficult to remove. Dilation-assisted stone extraction, also
 termed small endoscopic sphincterotomy plus endoscopic papillary large balloon dilatation, is
 safe and effective technique for the treatment of large CBD stones. However, in approximately
 5-10% of patients, the removal of large bile duct stones may be difficult. For this selected
 group of patients for whom all conventional endoscopic stone treatment devices have failed,
 laser lithotripsy technology has provided an approach to the fragmentation of difficult bile
 duct stones.

 A single-operator cholangioscopy (SOC) system (SpyGlass Direct Visualization System, Boston
 Scientific Corp., Natick, MA, USA) has overcome most of the conventional cholangioscopy
 limitations. The investigators aimed to evaluate the efficacy and safety of Spyglass-guided
 laser lithotripsy for difficult CBD stones not amenable to conventional dilation-assisted
 stone extraction therapy.
Purpose Very large bile duct stones are difficult to remove.Dilation-assisted stone
 extraction, also termed small endoscopic sphincterotomy plus endoscopic papillary large
 balloon dilatation, is safe and effective technique for the treatment of large CBD
 stones.However, in approximately 5-10% of patients, the removal of large bile duct stones may
 be difficult. For this selected group of patients for whom all conventional endoscopic stone
 treatment devices have failed, laser lithotripsy technology has provided an approach to the
 fragmentation of difficult bile duct stones.

 A single-operator cholangioscopy (SOC) system(SpyGlass Direct Visualization System, Boston
 Scientific Corp., Natick, MA, USA) has overcome most of the conventional cholangioscopy
 limitations.We aimed to evaluate the efficacy and safety of Spyglass-guided laser lithotripsy
 for difficult CBD stones not amenable to conventional dilation-assisted stone extraction
 therapy.

 Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification:
 Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
 Primary Purpose: Treatment Official Title: Randomized Trial of Spyglass Guided Laser
 Lithotripsy Versus Dilation-Assisted Stone Extraction for the Endoscopic Removal of Difficult
 Large Bile Duct Stones

 Primary Outcome Measures:

 • Bile Duct Stone Clearance Confirmation that no further stones remain in the bile duct of
 the patient by cholangiography. Additionally, serum laboratory abnormalities in AST, ALT,
 Alkaline Phophatase, or bilirubin, or epigastric abdominal pain attributable to bile duct
 stones.

 Secondary Outcome Measures:

 -  Number of ERCP

 -  The number of ERCP procedures required to complete clearance of bile duct stones.

 -  Total Procedure Time

 -  The total time in minutes for all the ERCP procedures required for stone removal.

 -  Estimated Procedure Cost

 -  The cost of patient management for bile duct stones based on the cost of the procedure,
 hospitalization, and associated costs of complications of cholangitis, pancreatitis,
 perforation, and bleeding.

 -  Cholangitis Cholangitis after or between ERCP procedures will be defined as a
 presentation with epigastric abdominal pain, temperature greater than 38.5 Celsius
 accompanied by either laboratory abnormalities of the AST, ALT, Alkaline Phosphatase, or
 Bilirubin or abnormal imaging of the biliary tree on ultrasound,computed tomography
 scan, or magnetic resonance cholangiopancreatography.

 -  Pancreatitis

 -  Pancreatitis following or between ERCP procedures will be defined as the onset of
 epigastric abdominal pain and either amylase or lipase greater than 3 times the upper
 limit of normal or findings on ultrasound, computed tomography scan, or magnetic
 resonance cholangiopancreatography suggestive of pancreatic inflammation.

 -  Bleeding

 -  Bleeding attributable to stone therapy will be defined as a drop in hemoglobin by more
 than 1 gm/dl following or between ERCP procedures with no other cause identified on
 standard clinical evaluation.

 Eligibility

 Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy
 Volunteers: No Criteria

 Inclusion Criteria:

 • Bile duct stone >1.5cm demonstrated on ultrasound, computed tomography, or magnetic
 resonance imaging

 Exclusion Criteria:

 -  Biliary, gallbladder or pancreatic malignancy

 -  Pregnant

 -  Prior biliary diversion surgery

 -  Under age 18

 -  Unable to give informed consent
Inclusion Criteria:

 -  Bile duct stone >1.5cm demonstrated on ultrasound, computed tomography, or magnetic
 resonance imaging

 Exclusion Criteria:

 -  Biliary, gallbladder or pancreatic malignancy

 -  Pregnant

 -  Prior biliary diversion surgery

 -  Under age 18

 -  Unable to give informed consent