Non-Complex Biliary Stones DSC vs ERC

The objective of this study is to prospectively compare non-complex biliary stone clearance
using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™
system with non-complex biliary stone clearance using standard endoscopic retrograde
cholangioscopy (ERC).

Inclusion Criteria:

1. 18 years or older

2. Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours
of onset of symptoms and imaging suggesting choledocholithiasis, contingent on
persistent abdominal pain)

3. Abnormal LFTs

4. Non-complex biliary stone disease, defined as 5 or fewer stones in the common bile or
common hepatic duct with largest stone no larger than 10 mm in size. If stones not
seen on imaging (US, CT) the bile duct diameter should be ≤12 mm*

* Given the poor sensitivity (approximately 20%) for biliary stones of CT and US, the
diameter of the dilated CBD is used as a surrogate for largest stone diameter

5. Availability of non-invasive imaging to determine the diameter of the bile duct and
number and size of bile duct stones if visible on imaging

1. If probability of stones is high per investigator assessment based on ASGE
criteria, any standard of practice imaging modality (eg. abdominal US) is
acceptable.

2. If the probability of stones is either intermediate or low per investigator
assessment based on ASGE criteria, MRCP or EUS imaging is required to confirm
presence of stones.

6. Willing and able to comply with the study procedures and provide written informed
consent to participate in the study

Exclusion Criteria:

1. Potentially vulnerable subjects, including but not limited to pregnant women and
subjects in whom an endoscopic procedure is contraindicated

2. Location of the stones in intrahepatic ducts, cystic duct or proximal to strictures

3. Bile duct stricture noted distal to stone on MRCP, which would make extraction without
lithotripsy impossible

4. Ongoing cholangitis at time of randomization, manifested by fever with tachycardia and
hypotension or evidence of pus at the ampulla

5. Patients with prior biliary sphincterotomy

6. Patients with Primary Sclerosing Cholangitis (PSC)

7. Acute pancreatitis, defined as abdominal pain and serum concentration of pancreatic
enzymes [lipase (required), amylase (optional)] three or more times the upper limit of
normal

8. Surgically altered gastro-duodenal luminal anatomy other than prior Billroth I
reconstruction, as these would be anticipated to lead to more complicated procedures

9. Coagulopathy or ongoing need for anti-coagulation