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

Not Applicable

Completed

• Conditions: Choledocholithiasis; Biliary Obstruction
• Interventions: Procedure: Cholangioscopy; Device: Spyglass DS Cholangioscope

• Registration Number: NCT03074201
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-08
• Primary Completion: 2017-05-20
• Study Completion: 2017-05-20
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-08
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cholangioscopy	Spyglass DS Cholangioscope	Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy
Cholangioscopy	Cholangioscopy	Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy

Primary Outcome Measures

Name	Time	Method
Stone clearance	During the cholangioscopy procedure	Successful clearance of stones from the bile duct using cholangioscopy

Secondary Outcome Measures

Name	Time	Method
Procedure Duration	5 minutes to 2.5 hours anticipated time frame	Duration of procedure

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States