Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP

Study Overview
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Brief Summary
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Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.

Official Title
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Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP

Conditions
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Choledocholithiasis, Biliary Obstruction

Intervention / Treatment
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* Procedure: Cholangioscopy
* Device: Spyglass DS Cholangioscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Non-complex biliary stone disease involving stones in the common bile or common hepatic duct. Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease. Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: Age <18 Potentially vulnerable subjects including, homeless people, pregnant females, employees and students. Participation in another related investigational study that could affect the results of this study within the previous 30 days Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective feasibility study to evaluate potential for cholangioscopy to facilitate radiation-free ERCP.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholangioscopy<br>Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy | Procedure: Cholangioscopy<br>* Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.<br>Device: Spyglass DS Cholangioscope<br>* Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone clearance | Successful clearance of stones from the bile duct using cholangioscopy | During the cholangioscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Duration | Duration of procedure | 5 minutes to 2.5 hours anticipated time frame | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, choledocholithiasis, cholangioscopy