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

September 8, 2018 updated by: Subhas Banerjee, Stanford University
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone clearance
Time Frame: During the cholangioscopy procedure
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
Time Frame: 5 minutes to 2.5 hours anticipated time frame
Duration of procedure
5 minutes to 2.5 hours anticipated time frame

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: up to 30 weeks post-procedure
Evaluation of adverse events following the procedure
up to 30 weeks post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

May 20, 2017

Study Completion (Actual)

May 20, 2017

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 8, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32194

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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