Biliary Obstruction, Choledocholithiasis
Conditions
Keywords
ERCP, choledocholithiasis, cholangioscopy
Brief summary
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.
Interventions
PROCEDURECholangioscopy
Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.
Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.
Sponsors
Boston Scientific Corporation
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Prospective feasibility study to evaluate potential for cholangioscopy to facilitate radiation-free ERCP.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 and above 2. Non-complex biliary stone disease involving stones in the common bile or common hepatic duct. 3. Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease. 4. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
1. Age \<18 2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students. 3. Participation in another related investigational study that could affect the results of this study within the previous 30 days 4. Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture) 5. Known bile duct infection (cholangitis defined as ongoing fevers on the day of the ERCP procedure or purulence evident at the ampulla or bile duct on cannulation/sphincterotomy. If clear bile is aspirated during the study procedure, we will proceed according to study procedures. If purulence is detected upon aspiration of bile during the procedure, patient will be excluded from the study and undergo standard radiation-based ERCP rather than cholangioscopy.) 5\) Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone clearance | During the cholangioscopy procedure | Successful clearance of stones from the bile duct using cholangioscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Duration | 5 minutes to 2.5 hours anticipated time frame | Duration of procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | up to 30 weeks post-procedure | Evaluation of adverse events following the procedure |
Countries
United States
Outcome results
None listed