Non-Complex Biliary Stones DSC vs ERC

Study Overview
=================
Brief Summary
-----------------
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 cholangiography (ERC).

Detailed Description
-----------------
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).

Official Title
-----------------
Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)

Conditions
-----------------
Biliary Stones

Intervention / Treatment
-----------------
* Device: DSC
* Device: ERC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain) Abnormal LFTs 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 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 If probability of stones is high per investigator assessment based on ASGE criteria, any standard of practice imaging modality (eg. abdominal US) is acceptable. 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. Willing and able to comply with the study procedures and provide written informed consent to participate in the study Exclusion Criteria: Potentially vulnerable subjects, including but not limited to pregnant women and subjects in whom an endoscopic procedure is contraindicated Location of the stones in intrahepatic ducts, cystic duct or proximal to strictures Bile duct stricture noted distal to stone on MRCP, which would make extraction without lithotripsy impossible Ongoing cholangitis at time of randomization, manifested by fever with tachycardia and hypotension or evidence of pus at the ampulla Patients with prior biliary sphincterotomy Patients with Primary Sclerosing Cholangitis (PSC) 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 Surgically altered gastro-duodenal luminal anatomy other than prior Billroth I reconstruction, as these would be anticipated to lead to more complicated procedures Coagulopathy or ongoing need for anti-coagulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ERC Arm<br>After screening examination and confirmed presence of non-complex bile duct stone by image, patients will be randomly assigned by stratified randomization to Electroscopic Retrograde Cholangioscopy (ERC) treatment. | Device: ERC<br>* Standard of care stone removal with fluoroscopy.<br>* Other names: Endoscopic Retrograde Cholangiography;|
| Other: DSC Arm<br>After screening examination and confirmed presence of non-complex bile duct stone by imagine, patients will be randomly assigned by stratified randomization to fluoroscopy/radiation-free direct solitary cholangioscopy (DSC). | Device: DSC<br>* Stone removal without fluoroscopy using the SpyGlass device.<br>* Other names: Direct Solitary Cholangioscopy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete stone clearance | Prospectively compare DSC vs. ERC | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event evaluation | To evaluate all SAEs including death, severity, onset, time to resolution. | 2 years | 
| Radiation Exposure | Measure of radiation exposure from duodenoscope in to completion of stone clearance. | 2 years | 
| Duration of Procedure | Defined as time from duodenoscope in to completion of stone clearance. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, DSC, Spy Glass, Biliary Stones, Choledocholithiasis, Non-Complex, Stones