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: Bile duct stones
Choledocholothiasis
10004606

Registration Number: NL-OMON49021

Lead Sponsor: Boston Scientific Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

* 18 years or older
* Abdominal pain consistent with choledocholithiasis
* Abnormal LFTs
* Non-complex biliary stone disease

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
* Surgically altered gastro-duodenal luminal anatomy other than prior Billroth
I Reconstruction
* Coagulopathy or ongoing need for anti-coagulation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Complete stone clearance by extraction of bile duct stones from the common bile<br /><br>duct (CBD) into duodenum as determined by<br /><br>fluoroscopy free cholangioscopy in the DSC arm and by cholangiography in the<br /><br>ERC arm.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluation of occurrence of SAEs between DSC arm vs ERC arm<br /><br>radiation exposure between DSC arm vs ERC arm<br /><br>Duration procedure DSC arm vs ERC arm</p><br>