Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
Primary Purpose
Choledocholithiasis, Biliary Obstruction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholangioscopy
Spyglass DS Cholangioscope
Sponsored by
About this trial
This is an interventional device feasibility trial for Choledocholithiasis focused on measuring ERCP, choledocholithiasis, cholangioscopy
Eligibility Criteria
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cholangioscopy
Arm Description
Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy
Outcomes
Primary Outcome Measures
Stone clearance
Successful clearance of stones from the bile duct using cholangioscopy
Secondary Outcome Measures
Procedure Duration
Duration of procedure
Full Information
NCT ID
NCT03074201
First Posted
February 23, 2017
Last Updated
September 8, 2018
Sponsor
Stanford University
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03074201
Brief Title
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
Official Title
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
May 20, 2017 (Actual)
Study Completion Date
May 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Biliary Obstruction
Keywords
ERCP, choledocholithiasis, cholangioscopy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective feasibility study to evaluate potential for cholangioscopy to facilitate radiation-free ERCP.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cholangioscopy
Arm Type
Experimental
Arm Description
Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy
Intervention Type
Procedure
Intervention Name(s)
Cholangioscopy
Intervention Description
Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.
Intervention Type
Device
Intervention Name(s)
Spyglass DS Cholangioscope
Intervention Description
Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.
Primary Outcome Measure Information:
Title
Stone clearance
Description
Successful clearance of stones from the bile duct using cholangioscopy
Time Frame
During the cholangioscopy procedure
Secondary Outcome Measure Information:
Title
Procedure Duration
Description
Duration of procedure
Time Frame
5 minutes to 2.5 hours anticipated time frame
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Evaluation of adverse events following the procedure
Time Frame
up to 30 weeks post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28797911
Citation
Barakat MT, Girotra M, Choudhary A, Huang RJ, Sethi S, Banerjee S. A prospective evaluation of radiation-free direct solitary cholangioscopy for the management of choledocholithiasis. Gastrointest Endosc. 2018 Feb;87(2):584-589.e1. doi: 10.1016/j.gie.2017.07.042. Epub 2017 Aug 7.
Results Reference
derived
Learn more about this trial
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
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